DyslipidemiasPLATINUMNCT03329729

PLATOREL® STUDY IN CARDIOVASCULAR RISΚ ASSESMENT

An observational study of Dyslipidemias and Hyperlipidemias, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Dyslipidemias are a major risk factor for the onset of cardiovascular disease, while early diagnosis and appropriate treatment approaches significantly reduce cardiovascular morbidity and mortality. The aim is to provide revised Greek guidelines for the diagnosis and treatment of dyslipidaemias. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Dyslipidemias, Hyperlipidemias, Risk Factor, Cardiovascular
What is being tested?: Rosuvastatin
How many people: 4,700 participants
Where: 1 siteGreece
Study dates: 1 Feb 2018to 30 Jan 2019
Phase: Observational
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with dyslipidemia and other risk factors treated with rosuvastatin

Who may be able to join

Outpatient Patients who are monitored at an external hospital for lipids, hypercholesterolemia, diabetes,
Male or female
Eligible ages for study: 18 - 99 years
Patients diagnosed with hypercholesterolemia who are to receive Rosuvastatin according to established clinical practice
Acquired cardiovascular disease from invasive or non-invasive examinations (such as coronary angiography, nuclear medicine, stress echocardiography, carotid plaque ultrasound), previous myocardial infarction, ACS, coronary revascularization (PCI, CABG), and other arterial revascularization, ischemic cerebrovascular accident, peripheral arterial disease (PAD) Diabetes mellitus (type 1 or type 2) with one or more cardiovascular risk factors orand target organ damage (such as microalbuminuria: 30-300 mg Patients already diagnosed with hypercholesterolemia and non-regulated who are going to receive Rosuvastatin according to established clinical practice
Patients who have fully understood the study protocol and have signed the consent document
Compliance with study procedures

Who cannot join

Patients <18 years
Hypersensitivity to Rosuvastatin or to any of the excipients
Women in gestation or lactation
Patients who have not fully understood the study protocol and have not signed the consent document

Trial locations and contacts

1 site in 1 country.

Greece1 site

Agia Olga Hospital
Athens

Other trials in Greece

About this study

Official title: Non-interventional, Multicenter Clinical Trial to Investigate the Efficacy of Rosuvastatin in Patients With Hyperlipidemia and Other Cardiovascular Risk Factors.

Dyslipidemias are a major risk factor for the onset of cardiovascular disease, while early diagnosis and appropriate treatment approaches significantly reduce cardiovascular morbidity and mortality.

The aim is to provide revised Greek guidelines for the diagnosis and treatment of dyslipidaemias.

The lipids of the human body are cholesterol (it is used to synthesize cell membranes, adrenal hormones and gonads and is a component of bile) and triglycerides (used as a fuel and as a storage of energy in adipose tissue). Dyslipidemias are disorders (quantitative or qualitative) of the metabolism of lipoprotein particles [low density lipoproteins (LDL), chylomic, high density lipoproteins (HDL), very low density lipoproteins (VLDL)] that carry lipids into the body.

Primary prevention in subjects aged 40-65 years with no known clinical atherosclerotic disease and without diabetes or chronic renal disease should evaluate the likelihood of a fatal cardiovascular event over the next 10 years. For this purpose, it is recommended to use the Greek version of the SCORE of the Hellenic Heart SCORE.

Read the detailed description

Rosuvastatin is a selective and competitive inhibitor of 3-hydroxy-3-methylglutaric coenzyme A (HMG-CoA), an enzyme regulating the rate of cholesterol synthesis. Its main area of action is the liver.

In cases of primary hypercholesterolaemia (type IIa, including familial hypercholesterolemia heterozygote) or mixed dyslipidaemia (type IIb) as a supplement to diet when dietary and other non-medication responses are inadequate.
In cases of homozygous familial hypercholesterolemia (HoFH), as a supplement to the diet and other lipid-lowering treatments.
In cases of slowing the progression of atherosclerosis. It is indicated as a supplemental treatment of the diet in lowering the total cholesterol (Total C) and LDL-C values.
In patients with hypertriglyceridaemia (excess triglycerides in the blood). Dosage and route of administration
In hyperlipidemia, mixed dyslipidaemia, hypertriglyceridaemia, and slowing the progression of atherosclerosis, the recommended starting dose is 10 mg once a day.
In homozygous familial hypercholesterolemia, the recommended starting dose is 20 mg once a day.
In Asian patients, the recommended starting dose is 5mg once a day.
In patients receiving ciclosporin, the dose of rosuvastatin should be set at 5 mg, while those taking the combination of Lopinavir

Conditions: Dyslipidemias, Hyperlipidemias, Risk Factor, Cardiovascular, Quality of Life
Being tested: Rosuvastatin
Medical subject headings: Dyslipidemias, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RosuvastatinOther
Hyperlipidemic patients treated with rosuvastatin

Study groups in NCT03329729
Study group	Role	What they receive
Hyperlipidemic patients		Not described Receives: Other: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to achieve LDL-C goal
To evaluate the efficacy of rosuvastatin in patients with hypercholesterolemia in achieving the target lipid level (LDL-C, HDL-C, T-CHOL) in patients' blood plasma
Measured: 6 months

Secondary outcomes (2)

CV Risk Factor
Assessing the Cardiovascular Disease Index - 10-year cardiovascular risk
Measured: 6 months
Quality of Life
Assessing Quality of Life in patients with hypercholesterolemia and other risk factors by EQ-5D questionnaire. The EQ- 5D is a descriptive, generic instrument that has also been validated for the Greek population and consists of two parts.25 The first part is a descriptive system of five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The second part consists of a visual analogue scale (VAS), the EQ-VAS, that asks respondents to self-rate themselves on a thermometer-like grading system in order to capture variations in health states. EQ-5D health state valuations may be converted into a single summary index by applying an algorithm that attaches values to each of the levels in each dimension. Value sets have been derived for the EQ-5D scores in several countries using either the VAS or the time trade-off (TTO) valuation technique.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201830 Jan 2019

First posted6 Nov 2017
Study start1 Feb 2018
Primary completion30 Jan 2019
Study completion30 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)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: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 4,700 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03329729
Sponsor's protocol ID: 2017-RSV-EL-78
Acronym: PLATINUM
Status last verified: Dec 2018
First submitted: 24 Oct 2017
Last updated: 13 May 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WMM, Vlachopoulos C, Wood DA, Zamorano JL, Cooney MT; ESC Scientific Document Group. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J. 2016 Oct 14;37(39):2999-3058. doi: 10.1093/eurheartj/ehw272. Epub 2016 Aug 27. No abstract available.
PubMed 27567407
European Association for Cardiovascular Prevention & Rehabilitation; Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines (CPG) 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28.
PubMed 21712404
Authors/Task Force Members:; Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WM, Vlachopoulos C, Wood DA, Zamorano JL. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias: The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) Developed with the special contribution of the European Assocciation for Cardiovascular Prevention & Rehabilitation (EACPR). Atherosclerosis. 2016 Oct;253:281-344. doi: 10.1016/j.atherosclerosis.2016.08.018. Epub 2016 Sep 1. No abstract available.
PubMed 27594540
Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS); Catapano AL, Reiner Z, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Perrone Filardi P, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Atherosclerosis. 2011 Jul;217 Suppl 1:S1-44. doi: 10.1016/j.atherosclerosis.2011.06.012. No abstract available.
PubMed 21723445
Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. No abstract available.
PubMed 21873419
Panagiotakos DB, Fitzgerald AP, Pitsavos C, Pipilis A, Graham I, Stefanadis C. Statistical modelling of 10-year fatal cardiovascular disease risk in Greece: the HellenicSCORE (a calibration of the ESC SCORE project). Hellenic J Cardiol. 2007 Mar-Apr;48(2):55-63.
PubMed 17489342
Panagiotakos DB, Georgousopoulou EN, Fitzgerald AP, Pitsavos C, Stefanadis C. Validation of the HellenicSCORE (a Calibration of the ESC SCORE Project) Regarding 10-Year Risk of Fatal Cardiovascular Disease in Greece. Hellenic J Cardiol. 2015 Jul-Aug;56(4):302-8.
PubMed 26233769
Pitsavos C, Panagiotakos DB, Chrysohoou C, Stefanadis C. Epidemiology of cardiovascular risk factors in Greece: aims, design and baseline characteristics of the ATTICA study. BMC Public Health. 2003 Oct 20;3:32. doi: 10.1186/1471-2458-3-32.
PubMed 14567760
Panagiotakos DB, Pitsavos C, Manios Y, Polychronopoulos E, Chrysohoou CA, Stefanadis C. Socio-economic status in relation to risk factors associated with cardiovascular disease, in healthy individuals from the ATTICA study. Eur J Cardiovasc Prev Rehabil. 2005 Feb;12(1):68-74.
PubMed 15703509
Kontodimopoulos N, Pappa E, Niakas D, Tountas Y. Validity of SF-12 summary scores in a Greek general population. Health Qual Life Outcomes. 2007 Sep 28;5:55. doi: 10.1186/1477-7525-5-55.
PubMed 17900374

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
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Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
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RecruitingObservational study
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All Dyslipidemias trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-interventional, Multicenter Clinical Trial to Investigate the Efficacy of Rosuvastatin in Patients With Hyperlipidemia and Other Cardiovascular Risk Factors.
ClinicalTrials.gov ID: NCT03329729
Acronym / sponsor ID: PLATINUM / 2017-RSV-EL-78
Conditions: Dyslipidemias, Hyperlipidemias, Risk Factor, Cardiovascular, Quality of Life
Study type: Observational
Recruitment status: Completed
Enrolment: 4,700 participants (actual)
Lead sponsor: Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
Study start: 1 Feb 2018 (actual)
Primary completion: 30 Jan 2019 (actual)
Study completion: 30 Jan 2019 (actual)
First posted: 6 Nov 2017 (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.

Dyslipidemias are a major risk factor for the onset of cardiovascular disease, while early diagnosis and appropriate treatment approaches significantly reduce cardiovascular morbidity and mortality.

The aim is to provide revised Greek guidelines for the diagnosis and treatment of dyslipidaemias.

Detailed description

Rosuvastatin is a selective and competitive inhibitor of 3-hydroxy-3-methylglutaric coenzyme A (HMG-CoA), an enzyme regulating the rate of cholesterol synthesis. Its main area of action is the liver.

In cases of primary hypercholesterolaemia (type IIa, including familial hypercholesterolemia heterozygote) or mixed dyslipidaemia (type IIb) as a supplement to diet when dietary and other non-medication responses are inadequate.
In cases of homozygous familial hypercholesterolemia (HoFH), as a supplement to the diet and other lipid-lowering treatments.
In cases of slowing the progression of atherosclerosis. It is indicated as a supplemental treatment of the diet in lowering the total cholesterol (Total C) and LDL-C values.
In patients with hypertriglyceridaemia (excess triglycerides in the blood). Dosage and route of administration
In hyperlipidemia, mixed dyslipidaemia, hypertriglyceridaemia, and slowing the progression of atherosclerosis, the recommended starting dose is 10 mg once a day.
In homozygous familial hypercholesterolemia, the recommended starting dose is 20 mg once a day.
In Asian patients, the recommended starting dose is 5mg once a day.
In patients receiving ciclosporin, the dose of rosuvastatin should be set at 5 mg, while those taking the combination of Lopinavir

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Hyperlipidemic patients	–	Other: Rosuvastatin

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with dyslipidemia and other risk factors treated with rosuvastatin

Key inclusion criteria (7 listed)

Outpatient Patients who are monitored at an external hospital for lipids, hypercholesterolemia, diabetes,
Male or female
Eligible ages for study: 18 - 99 years
Patients diagnosed with hypercholesterolemia who are to receive Rosuvastatin according to established clinical practice
Acquired cardiovascular disease from invasive or non-invasive examinations (such as coronary angiography, nuclear medicine, stress echocardiography, carotid plaque ultrasound), previous myocardial infarction, ACS, coronary revascularization (PCI, CABG), and other arterial revascularization, ischemic cerebrovascular accident, peripheral arterial disease (PAD) Diabetes mellitus (type 1 or type 2) with one or more cardiovascular risk factors orand target organ damage (such as microalbuminuria: 30-300 mg Patients already diagnosed with hypercholesterolemia and non-regulated who are going to receive Rosuvastatin according to established clinical practice

Key exclusion criteria (4 listed)

Patients <18 years
Hypersensitivity to Rosuvastatin or to any of the excipients
Women in gestation or lactation
Patients who have not fully understood the study protocol and have not signed the consent document

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
RosuvastatinHyperlipidemic patients treated with rosuvastatin	Other	Hyperlipidemic patients

Primary outcome

Time to achieve LDL-C goal
Time frame: 6 months
To evaluate the efficacy of rosuvastatin in patients with hypercholesterolemia in achieving the target lipid level (LDL-C, HDL-C, T-CHOL) in patients' blood plasma

2 secondary outcomes

CV Risk Factor
Time frame: 6 months
Quality of Life
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
Background: PubMed 27567407Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WMM, Vlachopoulos C, Wood DA, Zamorano JL, Cooney MT; ESC Scientific Document Group. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J. 2016 Oct 14;37(39):2999-3058. doi: 10.1093/eurheartj/ehw272. Epub 2016 Aug 27. No abstract available.
Background: PubMed 21712404European Association for Cardiovascular Prevention & Rehabilitation; Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines (CPG) 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28.
Background: PubMed 27594540Authors/Task Force Members:; Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WM, Vlachopoulos C, Wood DA, Zamorano JL. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias: The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) Developed with the special contribution of the European Assocciation for Cardiovascular Prevention & Rehabilitation (EACPR). Atherosclerosis. 2016 Oct;253:281-344. doi: 10.1016/j.atherosclerosis.2016.08.018. Epub 2016 Sep 1. No abstract available.
Background: PubMed 21723445Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS); Catapano AL, Reiner Z, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Perrone Filardi P, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Atherosclerosis. 2011 Jul;217 Suppl 1:S1-44. doi: 10.1016/j.atherosclerosis.2011.06.012. No abstract available.
Background: PubMed 21873419Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. No abstract available.
Background: PubMed 17489342Panagiotakos DB, Fitzgerald AP, Pitsavos C, Pipilis A, Graham I, Stefanadis C. Statistical modelling of 10-year fatal cardiovascular disease risk in Greece: the HellenicSCORE (a calibration of the ESC SCORE project). Hellenic J Cardiol. 2007 Mar-Apr;48(2):55-63.
Background: PubMed 26233769Panagiotakos DB, Georgousopoulou EN, Fitzgerald AP, Pitsavos C, Stefanadis C. Validation of the HellenicSCORE (a Calibration of the ESC SCORE Project) Regarding 10-Year Risk of Fatal Cardiovascular Disease in Greece. Hellenic J Cardiol. 2015 Jul-Aug;56(4):302-8.
Background: PubMed 14567760Pitsavos C, Panagiotakos DB, Chrysohoou C, Stefanadis C. Epidemiology of cardiovascular risk factors in Greece: aims, design and baseline characteristics of the ATTICA study. BMC Public Health. 2003 Oct 20;3:32. doi: 10.1186/1471-2458-3-32.
Background: PubMed 15703509Panagiotakos DB, Pitsavos C, Manios Y, Polychronopoulos E, Chrysohoou CA, Stefanadis C. Socio-economic status in relation to risk factors associated with cardiovascular disease, in healthy individuals from the ATTICA study. Eur J Cardiovasc Prev Rehabil. 2005 Feb;12(1):68-74.
Background: PubMed 17900374Kontodimopoulos N, Pappa E, Niakas D, Tountas Y. Validity of SF-12 summary scores in a Greek general population. Health Qual Life Outcomes. 2007 Sep 28;5:55. doi: 10.1186/1477-7525-5-55.
Individual participant dataSharing planned: Undecided

Related trials for Dyslipidemias

Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
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A Study to Evaluate COR-1004 in Adult Volunteers.
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Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dyslipidemias and Hyperlipidemias, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.

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 7 inclusion and 4 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: finished, as of the sponsor's last update on 13 May 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 Greece. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time to achieve LDL-C goal (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 NCT03329729, which also lists 10 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 13 May 2019.