HypercholesterolemiaPhase 3NCT00256178
Efficacy of Lapaquistat Acetate and Simvastatin in Subjects With Primary Dyslipidemia.
A Phase 3 study testing Lapaquistat acetate and simvastatin and Simvastatin in people with Hypercholesterolemia, run by Takeda at 53 sites in 7 countries.
Trial summary
The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with simvastatin on cholesterol levels in subjects with primary dyslipidemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Lapaquistat acetate and simvastatin and Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 53 sitesin 7 countries
- Study dates
- Oct 2005to Mar 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females of childbearing potential who are sexually active must agree to use adequate contraception from screening throughout the duration of the study and for 30 days following the last dose.
- Has a documented history of dyslipidemia with or without cardiovascular risk factors but without type 1 or 2 diabetes.
- Is on a stable dose of simvastatin, either 20 or 40 mg, for at least 4 weeks prior to Screening.
- Prior to Randomization, the participant has a mean low density lipoprotein cholesterol level greater than or equal to 100 mg/dL and less than or equal to 190 mg/dL for 2 consecutive samples.
- Prior to Randomization, the subject has mean triglyceride level greater than or equal to 400 mg/dL for 2 consecutive samples.
- Is willing and able to comply with the recommended, standardized diet.
Who cannot join
- Has annine aminotransferase or aspartate aminotransferase level greater than 1.5 times the upper limit of normal, identified during screening.
- Has a serum creatinine greater than 133 mmol/L, identified during screening.
- Has a creatine kinase greater than 3 times the upper limit of normal, identified during screening.
- Has active liver disease or jaundice.
- Has taken any bile acid sequestrants [eg, cholestyramine], and intestinal cholesterol uptake inhibitors [eg, ezetimibe]) from 30 days before Screening until study completion or any fibrates for 6 weeks before Visit 1.
- Has a previous history of cancer that has been in remission for less than 5 years prior to the first dose of study medication.
Show all 19Show fewer
- Has an endocrine disorder, such as Cushing's syndrome, hyperthyroidism, or inappropriately treated hypothyroidism affecting lipid metabolism.
- Has a history of myocardial infarction, angina pectoris, unstable angina, transient ischemic attacks, cerebrovascular accident, peripheral vascular disease, abdominal aortic aneurysm, coronary angioplasty, coronary or peripheral arterial surgery, or multiple risk factors that confer a 10-year risk for cardiovascular heart disease greater than 20% based on Framingham risk scoring.
- Has a positive hepatitis B surface antigen or hepatitis C virus antibody test, as determined by medical history.
- Has a positive human immunodeficiency virus status or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
- Has received any investigational medication 30 days prior to screening, (for drugs with a long half-life, within a period of less than 5 times the drug's half-life) or is participating in an investigational study.
- Has received lapaquistat acetate in a previous clinical study or as a therapeutic agent.
- Has a history or presence of clinically significant food allergy that would prevent adherence to the specialized diet.
- Has a known heterozygous or homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia (familial dysbetalipoproteinemia).
- Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.
- Has uncontrolled hypertension
- Has had inflammatory bowel disease or any other malabsorption syndrome, or has had gastric bypass or any other surgical procedure for weight loss.
- Has a history of drug abuse or a history of high alcohol intake within the previous 2 years.
- Has type 1 or 2 diabetes mellitus.
Trial locations and contacts
53 sites in 7 countries.
53 sites in 7 countries
United Kingdom12 sites
Study site
Bath
Study site
Birmingham
Study site
Blackpool
Study site
Blantyre
Study site
Chippenham
Study site
Eastwood
Study site
Glasgow
Study site
Harrow
Study site
Hinckley
Study site
Newport Isle of Wight
Study site
Nottingham
Study site
Woolpit
Czechia9 sites
Study site
Benešov
Study site
Holice V Čechách
Study site
Kladno
Study site
Mladá Boleslav
Study site
Olomouc
Study site
Prague
Study site
Trutnov
Study site
Ústí nad Orlicí
Study site
Zlín
Poland9 sites
Study site
Krakow
Study site
Lublin
Study site
Niemodlin
Study site
Skierniewice
Study site
Sroda Wlkp.
Study site
Starachowice
Study site
Swietokrzyski
Study site
Warsaw
Study site
Zakopane
Germany8 sites
Study site
Berlin
Study site
Bochum
Study site
Chemnitz
Study site
Dresden
Study site
Frankfurt
Study site
Görlitz
Study site
Leipzig
Study site
Nuremberg
Finland6 sites
Study site
Aura
Study site
Helsinki
Study site
Hyvinkää
Study site
Oulu
Study site
Tampere
Study site
Turku
South Africa6 sites
Study site
Bloemfontein
Study site
Cape Town
Study site
Johannesburg
Study site
Pretoria
Study site
Randburg
Study site
Tongaat
About this study
Official title: A Placebo-controlled, Double-blind, Randomized Study to Evaluate the Efficacy and Safety of TAK-475 50 mg and 100 mg Versus Placebo, When Co-administered With Simvastatin 20 mg or 40 mg in Subjects With Primary Dyslipidemia.
The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with simvastatin on cholesterol levels in subjects with primary dyslipidemia
Read the detailed description
In humans, cholesterol is acquired from dietary sources and is produced de novo in the liver, intestine, and various other tissues. Normally, the balance among cholesterol synthesis, dietary intake, and degradation is adequate to maintain healthy cholesterol plasma levels; however, in subjects with hypercholesterolemia, elevation in low-density lipoprotein cholesterol leads to atherosclerotic deposition of cholesterol in the arterial walls (atherosclerosis) and subsequent coronary heart disease. Thus, it has been established that lowering the low-density lipoprotein cholesterol plasma concentrations effectively reduces cardiovascular morbidity and mortality. Additional lipid risk factors for coronary heart disease include elevated triglyceride, very low-density lipoprotein cholesterol and low-density lipoprotein cholesterol levels, and low levels of high-density lipoprotein cholesterol.
Despite changes in lifestyle and the availability of potent lipid-lowering agents, cardiovascular disease continues to be the major cause of death in Western Europe and North America. Serum cholesterol levels exceeding 5 mmol/L (193 mg/dL) are common in adults in Britain and much of Europe, the United States, Australia, and New Zealand, representing a serious public health concern.
Currently, 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (ie, statins) are the first-line monotherapies prescribed for the treatment of dyslipidemia, after diet and therapeutic lifestyle changes alone fail to reduce low-density lipoprotein cholesterol to desired levels. Statins reduce low-density lipoprotein cholesterol and triglycerides, increase high-density lipoprotein cholesterol, and improve endothelial function. Treatment with statins reduces the risk of a vascular event by about 30% in subjects with and without symptoms of arteriosclerosis; however, many subjects fail to reach recommended levels of low-density lipoprotein cholesterol reduction after receiving low-dose statins as a monotherapy. Consequently, the dosage of statins is often increased or an additional treatment is added; the latter has become an important therapeutic option for achieving increasingly stringent lipid targets set forth by international therapeutic guidelines.
Simvastatin, a long-established treatment for dyslipidemia as monotherapy or in combination with other drugs, is a lactone that, once hydrolyzed, inhibits 3-hydroxy-3-methylglutaryl coenzyme A reductase. At the molecular level, the rate of synthesis of cholesterol depends primarily on the highly regulated activity of 3-hydroxy-3-methylglutaryl coenzyme A reductase.
TAK-475 (lapaquistat acetate) is a squalene synthase inhibitor currently under development at Takeda for the treatment of dyslipidemia. This study will evaluate the efficacy and safety of lapaquistat acetate taken with simvastatin in subjects with hypercholesterolemia. Total participation time in this study is expected to be up to 24 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- Lapaquistat acetate and simvastatin, Simvastatin
- Keywords
- Hyperlipidemia, Drug Therapy
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lapaquistat acetate and simvastatinDrug
Also called Lapaquistat, Zocor, TAK-475
Lapaquistat acetate 50 mg, tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks.
Lapaquistat acetate and simvastatinDrug
Also called Lapaquistat, Zocor, TAK-475
Lapaquistat acetate 100 mg, tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks.
SimvastatinDrug
Also called Zocor
Lapaquistat acetate placebo-matching tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lapaquistat Acetate 50 mg QD + Simvastatin | Experimental | Not described Receives: Drug: Lapaquistat acetate and simvastatin |
| Lapaquistat Acetate 100 mg QD + Simvastatin | Experimental | Not described Receives: Drug: Lapaquistat acetate and simvastatin |
| Simvastatin | Active comparator | Not described Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol
Measured: Week 24 or Final Visit
Secondary outcomes (20)
Change from Baseline in Triglycerides
Measured: Week 24 or Final Visit
Change from Baseline in Total Cholesterol
Measured: Week 24 or Final Visit
Change from Baseline in High Density Lipoprotein cholesterol
Measured: Week 24 or Final Visit
Change from Baseline in Very Low Density Lipoprotein cholesterol
Measured: Week 24 or Final Visit
Change from Baseline in apolipoprotein A1
Measured: Week 24 or Final Visit
Change from Baseline in apolipoprotein B
Measured: Week 24 or Final Visit
Change from Baseline in non- High Density Lipoprotein cholesterol
Measured: Week 24 or Final Visit
Change from Baseline in the ratio of Low Density Lipoprotein cholesterol/High Density Lipoprotein cholesterol
Measured: Week 24 or Final Visit
Change from Baseline in the ratio of Total Cholesterol/High Density Lipoprotein cholesterol
Measured: Week 24 or Final Visit
Change from Baseline in the ratio of apolipoprotein A1/apolipoprotein B
Measured: Week 24 or Final Visit
Change from Baseline in high-sensitivity C-reactive protein
Measured: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 1.81 mmol/L (70 mg/dL)
Measured: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 2.59 mmol/L (100 mg/dL)
Measured: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 3.37 mmol/L (130 mg/dL)
Measured: Week 24 or Final Visit
Best corrected visual acuity
Measured: Week 24 or Final Visit
Adverse Events
Measured: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Clinical Laboratory Tests
Measured: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Vital Signs
Measured: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit
12-lead Electrocardiogram
Measured: Timeframe: Weeks 12 and 24 or Final Visit
Physical Examination
Measured: Week 24 or Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256178
- Sponsor's protocol ID
- TAK-475/EC302
- Other IDs
- 2005-002313-21, U1111-1122-8212, 2005
- Status last verified
- May 2012
- First submitted
- 16 Nov 2005
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Stein EA, Bays H, O'Brien D, Pedicano J, Piper E, Spezzi A. Lapaquistat acetate: development of a squalene synthase inhibitor for the treatment of hypercholesterolemia. Circulation. 2011 May 10;123(18):1974-85. doi: 10.1161/CIRCULATIONAHA.110.975284. Epub 2011 Apr 25.
PubMed 21518985
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Double-blind, Randomized Study to Evaluate the Efficacy and Safety of TAK-475 50 mg and 100 mg Versus Placebo, When Co-administered With Simvastatin 20 mg or 40 mg in Subjects With Primary Dyslipidemia.
- ClinicalTrials.gov ID
- NCT00256178
- Acronym / sponsor ID
- TAK-475/EC302
- Conditions
- Hypercholesterolemia
- Keywords
- Hyperlipidemia, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 21 Nov 2005 (estimated)
- 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.
The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with simvastatin on cholesterol levels in subjects with primary dyslipidemia
Detailed description
In humans, cholesterol is acquired from dietary sources and is produced de novo in the liver, intestine, and various other tissues. Normally, the balance among cholesterol synthesis, dietary intake, and degradation is adequate to maintain healthy cholesterol plasma levels; however, in subjects with hypercholesterolemia, elevation in low-density lipoprotein cholesterol leads to atherosclerotic deposition of cholesterol in the arterial walls (atherosclerosis) and subsequent coronary heart disease. Thus, it has been established that lowering the low-density lipoprotein cholesterol plasma concentrations effectively reduces cardiovascular morbidity and mortality. Additional lipid risk factors for coronary heart disease include elevated triglyceride, very low-density lipoprotein cholesterol and low-density lipoprotein cholesterol levels, and low levels of high-density lipoprotein cholesterol.
Despite changes in lifestyle and the availability of potent lipid-lowering agents, cardiovascular disease continues to be the major cause of death in Western Europe and North America. Serum cholesterol levels exceeding 5 mmol/L (193 mg/dL) are common in adults in Britain and much of Europe, the United States, Australia, and New Zealand, representing a serious public health concern.
Currently, 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (ie, statins) are the first-line monotherapies prescribed for the treatment of dyslipidemia, after diet and therapeutic lifestyle changes alone fail to reduce low-density lipoprotein cholesterol to desired levels. Statins reduce low-density lipoprotein cholesterol and triglycerides, increase high-density lipoprotein cholesterol, and improve endothelial function. Treatment with statins reduces the risk of a vascular event by about 30% in subjects with and without symptoms of arteriosclerosis; however, many subjects fail to reach recommended levels of low-density lipoprotein cholesterol reduction after receiving low-dose statins as a monotherapy. Consequently, the dosage of statins is often increased or an additional treatment is added; the latter has become an important therapeutic option for achieving increasingly stringent lipid targets set forth by international therapeutic guidelines.
Simvastatin, a long-established treatment for dyslipidemia as monotherapy or in combination with other drugs, is a lactone that, once hydrolyzed, inhibits 3-hydroxy-3-methylglutaryl coenzyme A reductase. At the molecular level, the rate of synthesis of cholesterol depends primarily on the highly regulated activity of 3-hydroxy-3-methylglutaryl coenzyme A reductase.
TAK-475 (lapaquistat acetate) is a squalene synthase inhibitor currently under development at Takeda for the treatment of dyslipidemia. This study will evaluate the efficacy and safety of lapaquistat acetate taken with simvastatin in subjects with hypercholesterolemia. Total participation time in this study is expected to be up to 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lapaquistat Acetate 50 mg QD + Simvastatin | Experimental | Drug: Lapaquistat acetate and simvastatin |
| Lapaquistat Acetate 100 mg QD + Simvastatin | Experimental | Drug: Lapaquistat acetate and simvastatin |
| Simvastatin | Active comparator | Drug: Simvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females of childbearing potential who are sexually active must agree to use adequate contraception from screening throughout the duration of the study and for 30 days following the last dose.
- Has a documented history of dyslipidemia with or without cardiovascular risk factors but without type 1 or 2 diabetes.
- Is on a stable dose of simvastatin, either 20 or 40 mg, for at least 4 weeks prior to Screening.
- Prior to Randomization, the participant has a mean low density lipoprotein cholesterol level greater than or equal to 100 mg/dL and less than or equal to 190 mg/dL for 2 consecutive samples.
- Prior to Randomization, the subject has mean triglyceride level greater than or equal to 400 mg/dL for 2 consecutive samples.
Key exclusion criteria (19 listed)
- Has annine aminotransferase or aspartate aminotransferase level greater than 1.5 times the upper limit of normal, identified during screening.
- Has a serum creatinine greater than 133 mmol/L, identified during screening.
- Has a creatine kinase greater than 3 times the upper limit of normal, identified during screening.
- Has active liver disease or jaundice.
- Has taken any bile acid sequestrants [eg, cholestyramine], and intestinal cholesterol uptake inhibitors [eg, ezetimibe]) from 30 days before Screening until study completion or any fibrates for 6 weeks before Visit 1.
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 |
|---|---|---|
| Lapaquistat acetate and simvastatinAlso: Lapaquistat, Zocor, TAK-475Lapaquistat acetate 50 mg, tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks. | Drug | Lapaquistat Acetate 50 mg QD + Simvastatin |
| Lapaquistat acetate and simvastatinAlso: Lapaquistat, Zocor, TAK-475Lapaquistat acetate 100 mg, tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks. | Drug | Lapaquistat Acetate 100 mg QD + Simvastatin |
| SimvastatinAlso: ZocorLapaquistat acetate placebo-matching tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks. | Drug | Simvastatin |
Primary outcome
Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol
Time frame: Week 24 or Final Visit
20 secondary outcomes
Change from Baseline in Triglycerides
Time frame: Week 24 or Final Visit
Change from Baseline in Total Cholesterol
Time frame: Week 24 or Final Visit
Change from Baseline in High Density Lipoprotein cholesterol
Time frame: Week 24 or Final Visit
Change from Baseline in Very Low Density Lipoprotein cholesterol
Time frame: Week 24 or Final Visit
Change from Baseline in apolipoprotein A1
Time frame: Week 24 or Final Visit
Change from Baseline in apolipoprotein B
Time frame: Week 24 or Final Visit
Change from Baseline in non- High Density Lipoprotein cholesterol
Time frame: Week 24 or Final Visit
Change from Baseline in the ratio of Low Density Lipoprotein cholesterol/High Density Lipoprotein cholesterol
Time frame: Week 24 or Final Visit
Change from Baseline in the ratio of Total Cholesterol/High Density Lipoprotein cholesterol
Time frame: Week 24 or Final Visit
Change from Baseline in the ratio of apolipoprotein A1/apolipoprotein B
Time frame: Week 24 or Final Visit
Change from Baseline in high-sensitivity C-reactive protein
Time frame: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 1.81 mmol/L (70 mg/dL)
Time frame: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 2.59 mmol/L (100 mg/dL)
Time frame: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 3.37 mmol/L (130 mg/dL)
Time frame: Week 24 or Final Visit
Best corrected visual acuity
Time frame: Week 24 or Final Visit
Adverse Events
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Clinical Laboratory Tests
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Vital Signs
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit
12-lead Electrocardiogram
Time frame: Timeframe: Weeks 12 and 24 or Final Visit
Physical Examination
Time frame: Week 24 or Final Visit
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 24 May 2012.
- Results publication: PubMed 21518985Stein EA, Bays H, O'Brien D, Pedicano J, Piper E, Spezzi A. Lapaquistat acetate: development of a squalene synthase inhibitor for the treatment of hypercholesterolemia. Circulation. 2011 May 10;123(18):1974-85. doi: 10.1161/CIRCULATIONAHA.110.975284. Epub 2011 Apr 25.
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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.
Medical Director study director
Takeda
53 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lapaquistat acetate and simvastatin and Simvastatin in people with Hypercholesterolemia, run by Takeda at 53 sites in 7 countries.
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 6 inclusion and 19 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 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United Kingdom, Czechia, Poland, Germany, Finland and 2 more countries. 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?
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?
Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol (time frame: Week 24 or Final Visit). 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 NCT00256178, which also lists 1 linked publication.
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 24 May 2012.