DyslipidemiasPhase 3NCT03696940
Clinical Trial to Evaluate the Efficacy of a Dyslipidemic Therapy in Mexican Population
A Phase 3 study testing L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg and Atorvastatin 10mg in people with Dyslipidemias and Cardiovascular Risk Factor, run by Laboratorios Grossman, S.A. at 1 site in Mexico.
Trial summary
Clinical Trial Phase III, experimental, simple blind, randomized with two treatment groups, multicentric, longitudinal, to evaluate the therapuetic efficacy to dislipydemias in mexican adult population. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Dyslipidemias, Cardiovascular Risk Factor
- What is being tested?
- L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg and Atorvastatin 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMexico
- Study dates
- 28 May 2018to 31 Aug 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mexicans between 35 and 75 years of age.
- Gender indistinct.
- Patient with abnormal lipid profile considered as serum levels of Cholesterol LDL of 100mg/dl or greater, obtained by laboratory parameters.
- Not being under pharmacologic treatment to manage its dyslipidemia or accept to suspend current treatment and be evaluated for inclusion in the next 3 weeks starting on the day of initial evaluation.
- Women in fertile stage with a safe, hormonal-free family planning method. A safe planning method includes surgical methods in women, intrauterine device that doesn't release progestines and use of preservative in all their sexual relations.
- Women in fertile stage who don't wish to become pregnant during their participation in the study.
Show all 9Show fewer
- Post-menopause women or with hysterectomy history.
- Have a fixed and/or mobile telephone and accept to receive calls from the site for study processes.
- Grant their duly informed consent.
Who cannot join
- Subject lacking the mental capacity to understand the processes which imply their participation in the study and thus, not capable of granting their participation in a voluntary manner
- History of hypersensitivity to the medicines being studied.
- Daily intake of at least 240 mL of grape juice or sporadic ingestion of 1 liter.
- Potentially fertile women without a safe family planning method, who wish to become pregnant during the study, are already pregnant or in lactation period.
- Having on Globorisk scale for Mexicans, or as an associated risk factor, a high stratification for cardiovascular risk.
- Basal laboratory values with elevation of ALT 1.5 times larger than the upper limit considered normal according to international units.
Show all 31Show fewer
- Basal laboratory values with elevation of CPK not attributable to physical activity.
- Subjects who are under anticoagulant treatment, suffer from coagulation disorders, or any circumstance which contraindicates the taking of a blood.
- History of acute myocardial infarction, unstable angina, some confirmed coronopathy, arrhythmias, congestive cardiac failure or cerebrovascular disease.
- History of muscular conditions of the genetic type or of rhabdomyolysis in the patient or first degree relative.
- History or diagnose of congenital hepatic disorders, chronic infection by hepatitis virus, hepatitis with fatty liver, alcoholic hepatitis, primary biliary cirrhosis, primary sclerosis, cholangitis or hepatic failure.
- History or diagnose of congenital renal disorders, chronic renal failure, acute renal damage or nephritic syndrome.
- History of infection by Human Immunodeficiency Virus.
- History of Acute or Chronic Pancreatitis.
- History of the following endocrine diseases: non controlled Diabetes Mellitus, lipodystrophy, thyroid disorders, Cushing Syndrome and or Polycystic Ovary Syndrome.
- Diseases which compromise immunity such as Systemic Lupus Erythematous, Rheumatoid Arthritis, Antiphospholipid Antibodies Syndrome or Psoriasis.
- Diseases by deposit such as Gaucher Disease, disease by glycogen deposit, Tay Sachs juvenile disease or Niemann Pick Disease.
- Diagnose of Kawasaki Disease, Werner Syndrome, intermittent acute Porphyria, Idiopathic Hyperkalemia or Klinefelter Syndrome
- Suffer from Idiopathic Hyperkalemia, Klinefelter Syndrome, Werner Syndrome, Kawasaki Disease or Porphyria.
- History of epilepsy.
- History or diagnose of alcoholism.
- Intake of more than 20 grams of alcohol per day.
- User of marihuana.
- User of illegal drugs.
- Intake of medicines with pharmacologic interaction which increase or decrease the efficacy of L Carnitine and or atorvastatin or alter the lipids in blood such as Erythromycin, Telithromycin and Clarithromycin. Azole antifungi as Ketoconazole, Itraconazole, Fluconazole and Nefazodone. Quercetin, Amiodarone, Aprepitant, Cimetidine, Ciprofloxacin, Cyclosporine, Diltiazem, Imatinib, Echinacea, Enoxacin, Ergotamine, Metronidazole, Mifepristone, Tofisopam, Gestodene, Verapamil, Mibefradil, Fluoxetine, Phenobarbital, Carbamazepine, Phenytoin, Rifampin, Modafinil, Glucocorticoids, Felbamate, Rosiglitazone, Griseofulvin, Pioglitazone, Gemfibrozil, Clofibrate, Fenofibrate, Niacin, Nefazodone, Cholestyramine, Colchicine, Colestipol, Primidone, Topiramate, Troglitazone, Rifabutin, Digoxin, Thiazides, anabolic Steroids, Progestogens, Estrogens, Danazol, Amiodarone, fibric Acid, docosahexaenoic acid, Isotretinoine, Immunosuppressives, protease inhibitors of HIV or of the Hepatitis C Virus, Inhibitors of the cotransport of sodium glucose, Tamoxifen, Raloxifene, non selective Beta blockers, biliary acid sequestrants, asparginase, Sirolimus and Interferon.
- Patients who have been diagnosed with terminal conditions.
- Patients with recent Cancer diagnose or undergoing any type of therapy for same.
- Patients who have suffered skin cancer not of the melanoma type and have been cured and haven't been on treatment for at least 1 year before the start of their participation in the study may enter.
- Patients under lipid lowering treatment and who, because of their clinical condition aren't candidates to the period of lavage or detoxification; or well reject it.
- Being participating in another clinical trial or having concluded their participation in the 30 days previous to beginning their participation in this study.
- Any other which, at the Investigator's criteria, puts at risk the safety of the participant and or interferes with the results of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estudio clínico Fase III Para Evaluar la Eficacia terapéutica en Pacientes Mexicanos Con Dislipidemia Mediante el Uso vía Oral de L-Carnitina + Atorvastatina Comparado Con Atorvastatina
Clinical Trial Phase III, experimental, simple blind, randomized with two treatment groups, multicentric, longitudinal, to evaluate the therapuetic efficacy to dislipydemias in mexican adult population. This trial includes homogeneus populations that could be comparable by their disease condition, biologic characteristics and sociodemographics characteristics.
2 Treatment groups: Experimental Group: Oral Administration of L-carnitine (1g) + Oral Atorvastatin (20mg), every 24 hours for 6 months.
Read more
Active control group: Oral Administration of Atorvastatin 20mg every 24 hours for 6 months.
Sample Size: 120 subjects, females or males between 35 to 75 years old. Laboratory tests: Hematic biometry, quimical blood components, electrocardiogram and pregnancy urinary test.
Read the detailed description
General objectives:
Evaluate the therapeutic efficacy in Mexican adults with dyslipidemia through the oral route use of L-carnitine + atorvastatin in comparison with the use of Atorvastatin, after six months of treatment.
Evaluate the safety of the medicines under study.
Hypothesis:
The combined use of L-carnitine + atorvastatin offers therapeutic superiority with respect to the use of atorvastatin as treatment to reduce the percentage of C-LDL in patients with dyslipidemia.
The combination of L-carnitine + atorvastatin shows fewer incidences in the presence of adverse events attributable to the medicine in comparison to the use of atorvastatin as mono-therapy, in the treatment of dyslipidemia patients.
Design:
Phase III clinical assay, experimental randomized with two treatment, multi-centered, longitudinal, to evaluate the therapeutic efficacy in dyslipidemias of Mexican adults.
Material and Methods:
Sample Size 120 subjects will be included. Inclusion Criteria Mexicans between 35 and 75 years of age. Gender indistinct. Patient with abnormal lipid profile considered as serum levels of C-LDL of 100mg/dl or greater obtained by laboratory parameters.
Not under pharmacologic treatment to handle their dyslipidemia or accepting to suspend their current treatment and be evaluated for their inclusion in the next 3 weeks starting on the day of the initial evaluation.
Women in fertile stage with a safe, hormonal-free family planning method. A safe planning method includes surgical methods in women, intrauterine device that doesn't release progestines and use of preservative in all their sexual relations.
Women in fertile stage who don't wish to become pregnant during their participation in the study.
Post-menopause women or with hysterectomy history. Have a fixed and/or mobile telephone and accept to receive calls from the site for study processes.
Grant their duly informed consent. Exclusion Criteria Subject lacking the mental capacity to understand the processes which imply their participation in the study and thus,not capable of granting their participation in a voluntary manner.
History of hypersensitivity to the medicines being studied. Daily intake of at least 240ml of grape juice or sporadic ingestion of 1 liter. Potentially fertile women without a safe family planning method, who wish to become pregnant during the study, are already pregnant or in lactation period.
Having on Globorisk scale for Mexicans, or as an associated risk factor, a high stratification for cardiovascular risk.
Basal laboratory values with elevation of ALT 1.5 times larger than the upper limit considered normal according to international units.
Basal laboratory values with elevation of CPK not attributable to physical activity.
Subjects who are under anti-coagulant treatment, suffer from coagulation disorders, or any circumstance which contraindicates the taking of a blood.
History of acute myocardial infarction, unstable angina, some confirmed coronopathy, arrhythmias, congestive cardiac failure or cerebrovascular disease.
History of muscular conditions of the genetic type or of rhabdomyolysis in patient or first degree relative.
History or diagnose of congenital hepatic disorders, chronic infection by hepatitis virus, hepatitis with fatty liver, alcoholic hepatitis, primary biliary cirrhosis, primary sclerosis, cholangitis or hepatic failure.
History or diagnose of congenital renal disorders, chronic renal failure, acute renal damage or nephritic syndrome.
History of infection by Human Immunodeficiency Virus. History of Acute or Chronic Pancreatitis. History of the following endocrine diseases: non-controlled Diabetes Mellitus, lipodystrophy, thyroid disorders, Cushing Syndrome and/or Polycystic Ovary Syndrome.
Diseases which compromise immunity such as Systemic Lupus Erythematous, Rheumatoid Arthritis, Antiphospholipid Antibodies Syndrome or Psoriasis.
Diseases by deposit such as Gaucher Disease, disease by glycogen deposit, Tay-Sachs juvenile disease or Niemann Pick Disease.
Diagnose of Kawasaki Disease, Werner Syndrome, intermittent acute Porphyria, Idiopathic Hyperkalemia or Klinefelter Syndrome.
Suffer from Idiopathic Hyperkalemia, Klinefelter Syndrome, Werner Syndrome, Kawasaki Disease or Porphyria.
History of epilepsy. History or diagnose of alcoholism. Intake of more than 20g of alcohol per day. User of marihuana. User of illegal drugs.
Intake of medicines with pharmacologic interaction which increase or decrease the efficacy of L-Carnitine and/or atorvastatin or alter the lipids in blood such as:
Macrolide antibiotics: Erythromycin, Telithromycin and Clarithromycin. Azole anti-fungi: Ketoconazole, Itraconazole, Fluconazole and Nefazodone. Quercetin, Amiodarone, Aprepitant, Cimetidine, Ciprofloxacin, Cyclosporine, Diltiazem, Imatinib, Echinacea, Enoxacin, Ergotamine, Metronidazole, Mifepristone, Tofisopam, Gestodene, Verapamil, Mibefradil, Fluoxetine, Phenobarbital, Carbamazepine, Phenytoin, Rifampin, Modafinil, Glucocorticoids, Felbamate, Rosiglitazone, Griseofulvin, Pioglitazone, Gemfibrozil, Clofibrate, Fenofibrate, Niacin, Nefazodone, Cholestyramine, Colchicine, Colestipol, Primidone, Topiramate, Troglitazone, Rifabutin, Digoxin, Thiazides, anabolic Steroids, Progestogens, Estrogens, Danazol, Amiodarone, fibric Acid, docosahexaenoic acid, Isotretinoine, Immunosuppressives, protease inhibitors of HIV or of the Hepatitis C Virus, Inhibitors of the co-transport of sodium-glucose, Tamoxifen, Raloxifene, non-selective Beta blockers, biliary acid sequestrants, asparginase, Sirolimus and Interferon.
Patients who have been diagnosed with terminal conditions. Patients with recent Cancer diagnose or undergoing any type of therapy for same. Patients who have suffered skin cancer not of the melanoma type and have been cured and haven't been on treatment for at least 1 year before the start of their participation in the study may enter.
Patients under lipid lowering treatment and who, because of their clinical condition aren't candidates to the period of lavage or detoxification; or well reject same.
Been participating in another clinical trial or having concluded their participation in the 30 days previous to beginning their participation in this study.
Any other which, at the Investigator's criteria, puts at risk the safety of the participant and/or interferes with the results of the study.
Medicine L-Carnitine, Atorvastatin Dose L-Carnitine 1 g + Atorvastatin 20 mg daily for 6 months and Atorvastatin 20 mg daily for 6 months
Efficacy criteria:
The efficacy of the combined treatment vs. atorvastatin in mono-therapy for dyslipidemia will be compared, through evaluation of the variability of the biochemical parameters at the start and end of the study.
- Conditions
- Dyslipidemias, Cardiovascular Risk Factor
- Being tested
- L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg, Atorvastatin 10mg
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mgDrug
Also called Experimental Group
Oral administration of 2 tablets of atorvastatin 10 mg (each one) every 24 hours for 6 months.
Atorvastatin 10mgDrug
Also called Active control group
Oral administration of 2 tablets atorvastatin 10 mg (each one) every 24 hours for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 2 tablets of: L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg Receives: Drug: L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg |
| Control Group | Active comparator | 2 tablets of: Atorvastatin 10 mg Receives: Drug: Atorvastatin 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of experimental treatment by the change in Cholesterol LDL
Evaluate the change of atorvastatin + l-carnitine vs. atorvastatin alone for dyslipidemia, through change of C-LDL in mg/dl
Measured: 6 months
Secondary outcomes (5)
Efficacy of experimental treatment by the change in Cholesterol no-HDL
Evaluate the change of Cholesterol no-HDL in Mexican adults with dyslipidemia through the use of oral route L-carnitine + atorvastatin in comparison with the use of Atorvastatin, after six months of treatment.
Measured: 6 months
Efficacy of experimental treatment by the change in Total serum Cholesterol
Evaluate the change of serum levels of Cholesterol in mg/dl in Mexican adults with dyslipidemia through the use of oral route L-carnitine + atorvastatin in comparison with the use of Atorvastatin, after six months of treatment.
Measured: 6 months
Efficacy of experimental treatment by the change in Triglycerides
Evaluate the reduction of serum levels of Triglycerides in mg/dl in Mexican adults with dyslipidemia through the use of oral route L-carnitine + atorvastatin in comparison with the use of Atorvastatin, after six months of treatment
Measured: 6 months
Efficacy of experimental treatment by the change in Cholesterol HDL
Evaluate the change of serum levels of Cholesterol HDL in mg/dl in Mexican adults with dyslipidemia through the use of oral route L-carnitine + atorvastatin in comparison with the use of Atorvastatin, after six months of treatment
Measured: 6 months
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
Evaluate the incidence, of serious and non-serious adverse events related through the oral route administration of L-carnitine + atorvastatin in comparison with the use of Atorvastatin, after six months of treatment in the subjects participating in the study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start28 May 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (117)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Grossman, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto Nacional de Salud Publica, Mexico
- Responsible party
- Sponsor
- Investigators
- Aurelio Cruz Valdez, PhD, Principal investigator, Instituto Nacional de Salud PúblicaJosé Flores Figueroa, PhD, Principal investigator, JM Research, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696940
- Sponsor's protocol ID
- GMX-001-2017
- Status last verified
- Feb 2019
- First submitted
- 18 Sep 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bou Malham S, Goldberg AC. Cardiovascular risk reduction: the future of cholesterol lowering drugs. Curr Opin Pharmacol. 2016 Apr;27:62-9. doi: 10.1016/j.coph.2016.01.007. Epub 2016 Mar 2.
PubMed 26939026Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available.
PubMed 27222591Rosenson RS, Baker SK, Jacobson TA, Kopecky SL, Parker BA, The National Lipid Association's Muscle Safety Expert Panel. An assessment by the Statin Muscle Safety Task Force: 2014 update. J Clin Lipidol. 2014 May-Jun;8(3 Suppl):S58-71. doi: 10.1016/j.jacl.2014.03.004.
PubMed 24793443Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-934. doi: 10.1016/j.jacc.2013.11.002. Epub 2013 Nov 12. No abstract available.
PubMed 24239923Lee BJ, Lin JS, Lin YC, Lin PT. Effects of L-carnitine supplementation on lipid profiles in patients with coronary artery disease. Lipids Health Dis. 2016 Jun 17;15:107. doi: 10.1186/s12944-016-0277-5.
PubMed 27317162Chawla A, Repa JJ, Evans RM, Mangelsdorf DJ. Nuclear receptors and lipid physiology: opening the X-files. Science. 2001 Nov 30;294(5548):1866-70. doi: 10.1126/science.294.5548.1866.
PubMed 11729302Barter PJ, Rye KA. Relationship between the concentration and antiatherogenic activity of high-density lipoproteins. Curr Opin Lipidol. 2006 Aug;17(4):399-403. doi: 10.1097/01.mol.0000236365.40969.af.
PubMed 16832163Cooney MT, Dudina A, De Bacquer D, Wilhelmsen L, Sans S, Menotti A, De Backer G, Jousilahti P, Keil U, Thomsen T, Whincup P, Graham IM; SCORE investigators. HDL cholesterol protects against cardiovascular disease in both genders, at all ages and at all levels of risk. Atherosclerosis. 2009 Oct;206(2):611-6. doi: 10.1016/j.atherosclerosis.2009.02.041. Epub 2009 Mar 19.
PubMed 19375079Anderson TJ, Gregoire J, Hegele RA, Couture P, Mancini GB, McPherson R, Francis GA, Poirier P, Lau DC, Grover S, Genest J Jr, Carpentier AC, Dufour R, Gupta M, Ward R, Leiter LA, Lonn E, Ng DS, Pearson GJ, Yates GM, Stone JA, Ur E. 2012 update of the Canadian Cardiovascular Society guidelines for the diagnosis and treatment of dyslipidemia for the prevention of cardiovascular disease in the adult. Can J Cardiol. 2013 Feb;29(2):151-67. doi: 10.1016/j.cjca.2012.11.032.
PubMed 23351925Wadhera RK, Steen DL, Khan I, Giugliano RP, Foody JM. A review of low-density lipoprotein cholesterol, treatment strategies, and its impact on cardiovascular disease morbidity and mortality. J Clin Lipidol. 2016 May-Jun;10(3):472-89. doi: 10.1016/j.jacl.2015.11.010. Epub 2015 Nov 25.
PubMed 27206934National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.
PubMed 12485966Aguilar-Salinas CA, Canizales-Quinteros S, Rojas-Martinez R, Garcia-Garcia E, Olaiz-Fernandez G, Gomez-Perez FJ, Tusie-Luna MT. [Succesful collaborations between three Mexican institutions for research on dislipidemias, obesity and diabetes]. Gac Med Mex. 2007 Sep-Oct;143(5):355-64. Spanish.
PubMed 18246928Escobedo-de la Pena J, de Jesus-Perez R, Schargrodsky H, Champagne B. [Prevalence of dyslipidemias in Mexico city and Its relation to other cardiovascular risk factors. Results from the CARMELA study]. Gac Med Mex. 2014 Mar-Apr;150(2):128-36. Spanish.
PubMed 24603993Aguilar Salinas CA, Zamora M, Gomez-Diaz RA, Mehta R, Gomez Perez FJ, Rull JA. Familial combined hyperlipidemia: controversial aspects of its diagnosis and pathogenesis. Semin Vasc Med. 2004 May;4(2):203-9. doi: 10.1055/s-2004-835379.
PubMed 15478042Badzioch MD, Igo RP Jr, Gagnon F, Brunzell JD, Krauss RM, Motulsky AG, Wijsman EM, Jarvik GP. Low-density lipoprotein particle size loci in familial combined hyperlipidemia: evidence for multiple loci from a genome scan. Arterioscler Thromb Vasc Biol. 2004 Oct;24(10):1942-50. doi: 10.1161/01.ATV.0000143499.09575.93. Epub 2004 Aug 26.
PubMed 15331429
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio clínico Fase III Para Evaluar la Eficacia terapéutica en Pacientes Mexicanos Con Dislipidemia Mediante el Uso vía Oral de L-Carnitina + Atorvastatina Comparado Con Atorvastatina
- ClinicalTrials.gov ID
- NCT03696940
- Acronym / sponsor ID
- GMX-001-2017
- Conditions
- Dyslipidemias, Cardiovascular Risk Factor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Laboratorios Grossman, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Instituto Nacional de Salud Publica, Mexico
- Study start
- 28 May 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Trial Phase III, experimental, simple blind, randomized with two treatment groups, multicentric, longitudinal, to evaluate the therapuetic efficacy to dislipydemias in mexican adult population. This trial includes homogeneus populations that could be comparable by their disease condition, biologic characteristics and sociodemographics characteristics.
2 Treatment groups: Experimental Group: Oral Administration of L-carnitine (1g) + Oral Atorvastatin (20mg), every 24 hours for 6 months.
Active control group: Oral Administration of Atorvastatin 20mg every 24 hours for 6 months.
Sample Size: 120 subjects, females or males between 35 to 75 years old. Laboratory tests: Hematic biometry, quimical blood components, electrocardiogram and pregnancy urinary test.
Detailed description
General objectives:
Evaluate the therapeutic efficacy in Mexican adults with dyslipidemia through the oral route use of L-carnitine + atorvastatin in comparison with the use of Atorvastatin, after six months of treatment.
Evaluate the safety of the medicines under study.
Hypothesis:
The combined use of L-carnitine + atorvastatin offers therapeutic superiority with respect to the use of atorvastatin as treatment to reduce the percentage of C-LDL in patients with dyslipidemia.
The combination of L-carnitine + atorvastatin shows fewer incidences in the presence of adverse events attributable to the medicine in comparison to the use of atorvastatin as mono-therapy, in the treatment of dyslipidemia patients.
Design:
Phase III clinical assay, experimental randomized with two treatment, multi-centered, longitudinal, to evaluate the therapeutic efficacy in dyslipidemias of Mexican adults.
Material and Methods:
Sample Size 120 subjects will be included. Inclusion Criteria Mexicans between 35 and 75 years of age. Gender indistinct. Patient with abnormal lipid profile considered as serum levels of C-LDL of 100mg/dl or greater obtained by laboratory parameters.
Not under pharmacologic treatment to handle their dyslipidemia or accepting to suspend their current treatment and be evaluated for their inclusion in the next 3 weeks starting on the day of the initial evaluation.
Women in fertile stage with a safe, hormonal-free family planning method. A safe planning method includes surgical methods in women, intrauterine device that doesn't release progestines and use of preservative in all their sexual relations.
Women in fertile stage who don't wish to become pregnant during their participation in the study.
Post-menopause women or with hysterectomy history. Have a fixed and/or mobile telephone and accept to receive calls from the site for study processes.
Grant their duly informed consent. Exclusion Criteria Subject lacking the mental capacity to understand the processes which imply their participation in the study and thus,not capable of granting their participation in a voluntary manner.
History of hypersensitivity to the medicines being studied. Daily intake of at least 240ml of grape juice or sporadic ingestion of 1 liter. Potentially fertile women without a safe family planning method, who wish to become pregnant during the study, are already pregnant or in lactation period.
Having on Globorisk scale for Mexicans, or as an associated risk factor, a high stratification for cardiovascular risk.
Basal laboratory values with elevation of ALT 1.5 times larger than the upper limit considered normal according to international units.
Basal laboratory values with elevation of CPK not attributable to physical activity.
Subjects who are under anti-coagulant treatment, suffer from coagulation disorders, or any circumstance which contraindicates the taking of a blood.
History of acute myocardial infarction, unstable angina, some confirmed coronopathy, arrhythmias, congestive cardiac failure or cerebrovascular disease.
History of muscular conditions of the genetic type or of rhabdomyolysis in patient or first degree relative.
History or diagnose of congenital hepatic disorders, chronic infection by hepatitis virus, hepatitis with fatty liver, alcoholic hepatitis, primary biliary cirrhosis, primary sclerosis, cholangitis or hepatic failure.
History or diagnose of congenital renal disorders, chronic renal failure, acute renal damage or nephritic syndrome.
History of infection by Human Immunodeficiency Virus. History of Acute or Chronic Pancreatitis. History of the following endocrine diseases: non-controlled Diabetes Mellitus, lipodystrophy, thyroid disorders, Cushing Syndrome and/or Polycystic Ovary Syndrome.
Diseases which compromise immunity such as Systemic Lupus Erythematous, Rheumatoid Arthritis, Antiphospholipid Antibodies Syndrome or Psoriasis.
Diseases by deposit such as Gaucher Disease, disease by glycogen deposit, Tay-Sachs juvenile disease or Niemann Pick Disease.
Diagnose of Kawasaki Disease, Werner Syndrome, intermittent acute Porphyria, Idiopathic Hyperkalemia or Klinefelter Syndrome.
Suffer from Idiopathic Hyperkalemia, Klinefelter Syndrome, Werner Syndrome, Kawasaki Disease or Porphyria.
History of epilepsy. History or diagnose of alcoholism. Intake of more than 20g of alcohol per day. User of marihuana. User of illegal drugs.
Intake of medicines with pharmacologic interaction which increase or decrease the efficacy of L-Carnitine and/or atorvastatin or alter the lipids in blood such as:
Macrolide antibiotics: Erythromycin, Telithromycin and Clarithromycin. Azole anti-fungi: Ketoconazole, Itraconazole, Fluconazole and Nefazodone. Quercetin, Amiodarone, Aprepitant, Cimetidine, Ciprofloxacin, Cyclosporine, Diltiazem, Imatinib, Echinacea, Enoxacin, Ergotamine, Metronidazole, Mifepristone, Tofisopam, Gestodene, Verapamil, Mibefradil, Fluoxetine, Phenobarbital, Carbamazepine, Phenytoin, Rifampin, Modafinil, Glucocorticoids, Felbamate, Rosiglitazone, Griseofulvin, Pioglitazone, Gemfibrozil, Clofibrate, Fenofibrate, Niacin, Nefazodone, Cholestyramine, Colchicine, Colestipol, Primidone, Topiramate, Troglitazone, Rifabutin, Digoxin, Thiazides, anabolic Steroids, Progestogens, Estrogens, Danazol, Amiodarone, fibric Acid, docosahexaenoic acid, Isotretinoine, Immunosuppressives, protease inhibitors of HIV or of the Hepatitis C Virus, Inhibitors of the co-transport of sodium-glucose, Tamoxifen, Raloxifene, non-selective Beta blockers, biliary acid sequestrants, asparginase, Sirolimus and Interferon.
Patients who have been diagnosed with terminal conditions. Patients with recent Cancer diagnose or undergoing any type of therapy for same. Patients who have suffered skin cancer not of the melanoma type and have been cured and haven't been on treatment for at least 1 year before the start of their participation in the study may enter.
Patients under lipid lowering treatment and who, because of their clinical condition aren't candidates to the period of lavage or detoxification; or well reject same.
Been participating in another clinical trial or having concluded their participation in the 30 days previous to beginning their participation in this study.
Any other which, at the Investigator's criteria, puts at risk the safety of the participant and/or interferes with the results of the study.
Medicine L-Carnitine, Atorvastatin Dose L-Carnitine 1 g + Atorvastatin 20 mg daily for 6 months and Atorvastatin 20 mg daily for 6 months
Efficacy criteria:
The efficacy of the combined treatment vs. atorvastatin in mono-therapy for dyslipidemia will be compared, through evaluation of the variability of the biochemical parameters at the start and end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Longitudinal
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg2 tablets of: L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg |
| Control Group | Active comparator | Drug: Atorvastatin 10mg2 tablets of: Atorvastatin 10 mg |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Mexicans between 35 and 75 years of age.
- Gender indistinct.
- Patient with abnormal lipid profile considered as serum levels of Cholesterol LDL of 100mg/dl or greater, obtained by laboratory parameters.
- Not being under pharmacologic treatment to manage its dyslipidemia or accept to suspend current treatment and be evaluated for inclusion in the next 3 weeks starting on the day of initial evaluation.
- Women in fertile stage with a safe, hormonal-free family planning method. A safe planning method includes surgical methods in women, intrauterine device that doesn't release progestines and use of preservative in all their sexual relations.
Key exclusion criteria (31 listed)
- Subject lacking the mental capacity to understand the processes which imply their participation in the study and thus, not capable of granting their participation in a voluntary manner
- History of hypersensitivity to the medicines being studied.
- Daily intake of at least 240 mL of grape juice or sporadic ingestion of 1 liter.
- Potentially fertile women without a safe family planning method, who wish to become pregnant during the study, are already pregnant or in lactation period.
- Having on Globorisk scale for Mexicans, or as an associated risk factor, a high stratification for cardiovascular risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mgAlso: Experimental GroupOral administration of 2 tablets of atorvastatin 10 mg (each one) every 24 hours for 6 months. | Drug | Experimental Group |
| Atorvastatin 10mgAlso: Active control groupOral administration of 2 tablets atorvastatin 10 mg (each one) every 24 hours for 6 months. | Drug | Control Group |
Primary outcome
Efficacy of experimental treatment by the change in Cholesterol LDL
Time frame: 6 months
Evaluate the change of atorvastatin + l-carnitine vs. atorvastatin alone for dyslipidemia, through change of C-LDL in mg/dl
5 secondary outcomes
Efficacy of experimental treatment by the change in Cholesterol no-HDL
Time frame: 6 months
Efficacy of experimental treatment by the change in Total serum Cholesterol
Time frame: 6 months
Efficacy of experimental treatment by the change in Triglycerides
Time frame: 6 months
Efficacy of experimental treatment by the change in Cholesterol HDL
Time frame: 6 months
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Results publication: PubMed 26939026Bou Malham S, Goldberg AC. Cardiovascular risk reduction: the future of cholesterol lowering drugs. Curr Opin Pharmacol. 2016 Apr;27:62-9. doi: 10.1016/j.coph.2016.01.007. Epub 2016 Mar 2.
- Results publication: PubMed 27222591Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available.
- Results publication: PubMed 24793443Rosenson RS, Baker SK, Jacobson TA, Kopecky SL, Parker BA, The National Lipid Association's Muscle Safety Expert Panel. An assessment by the Statin Muscle Safety Task Force: 2014 update. J Clin Lipidol. 2014 May-Jun;8(3 Suppl):S58-71. doi: 10.1016/j.jacl.2014.03.004.
- Results publication: PubMed 24239923Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-934. doi: 10.1016/j.jacc.2013.11.002. Epub 2013 Nov 12. No abstract available.
- Results publication: PubMed 27317162Lee BJ, Lin JS, Lin YC, Lin PT. Effects of L-carnitine supplementation on lipid profiles in patients with coronary artery disease. Lipids Health Dis. 2016 Jun 17;15:107. doi: 10.1186/s12944-016-0277-5.
- Results publication: PubMed 11729302Chawla A, Repa JJ, Evans RM, Mangelsdorf DJ. Nuclear receptors and lipid physiology: opening the X-files. Science. 2001 Nov 30;294(5548):1866-70. doi: 10.1126/science.294.5548.1866.
- Results publication: PubMed 16832163Barter PJ, Rye KA. Relationship between the concentration and antiatherogenic activity of high-density lipoproteins. Curr Opin Lipidol. 2006 Aug;17(4):399-403. doi: 10.1097/01.mol.0000236365.40969.af.
- Results publication: PubMed 19375079Cooney MT, Dudina A, De Bacquer D, Wilhelmsen L, Sans S, Menotti A, De Backer G, Jousilahti P, Keil U, Thomsen T, Whincup P, Graham IM; SCORE investigators. HDL cholesterol protects against cardiovascular disease in both genders, at all ages and at all levels of risk. Atherosclerosis. 2009 Oct;206(2):611-6. doi: 10.1016/j.atherosclerosis.2009.02.041. Epub 2009 Mar 19.
- Results publication: PubMed 23351925Anderson TJ, Gregoire J, Hegele RA, Couture P, Mancini GB, McPherson R, Francis GA, Poirier P, Lau DC, Grover S, Genest J Jr, Carpentier AC, Dufour R, Gupta M, Ward R, Leiter LA, Lonn E, Ng DS, Pearson GJ, Yates GM, Stone JA, Ur E. 2012 update of the Canadian Cardiovascular Society guidelines for the diagnosis and treatment of dyslipidemia for the prevention of cardiovascular disease in the adult. Can J Cardiol. 2013 Feb;29(2):151-67. doi: 10.1016/j.cjca.2012.11.032.
- Results publication: PubMed 27206934Wadhera RK, Steen DL, Khan I, Giugliano RP, Foody JM. A review of low-density lipoprotein cholesterol, treatment strategies, and its impact on cardiovascular disease morbidity and mortality. J Clin Lipidol. 2016 May-Jun;10(3):472-89. doi: 10.1016/j.jacl.2015.11.010. Epub 2015 Nov 25.
- Results publication: PubMed 12485966National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.
- Results publication: PubMed 18246928Aguilar-Salinas CA, Canizales-Quinteros S, Rojas-Martinez R, Garcia-Garcia E, Olaiz-Fernandez G, Gomez-Perez FJ, Tusie-Luna MT. [Succesful collaborations between three Mexican institutions for research on dislipidemias, obesity and diabetes]. Gac Med Mex. 2007 Sep-Oct;143(5):355-64. Spanish.
- World Health Organization: Global Status report on non-communicable diseases 2014.Link provided by the sponsor.
- Protocolo clínico para el diagnóstico y tratamiento de las Dislipidemias. CENAPRECE, Secretaría e Salud, D.F. México.Link provided by the sponsor.
- Treatment of lipids (including hypercholesterolemia) in secondary prevention.Link provided by the sponsor.
- Organization for Economic Cooperation and Development.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurelio Cruz Valdez, PhD principal investigator
Instituto Nacional de Salud Pública
José Flores Figueroa, PhD principal investigator
JM Research, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg and Atorvastatin 10mg in people with Dyslipidemias and Cardiovascular Risk Factor, run by Laboratorios Grossman, S.A. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of experimental treatment by the change in Cholesterol LDL (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03696940, which also lists 117 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.