- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00532558
Efficacy of Lapaquistat Acetate on Blood Cholesterol Levels in Treating Subjects With Hypercholesterolemia
May 23, 2012 updated by: Takeda
A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 50 mg vs Placebo in Subjects With Hypercholesterolemia, With an Optional Open-Label Extension
The purpose of the study is to determine the reduction of LDL-cholesterol level after treatment with 50 mg per day of lapaquistat acetate once daily (QD).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This study is being conducted to determine the potential of lapaquistat acetate 50 mg per day to lower LDL-C levels compared with placebo.
This study is also being conducted to further evaluate the safety and tolerability of lapaquistat acetate 50 mg over a period of 12 weeks.
An optional, 48-week, open-label extension will follow the 12 week, double-blind treatment period to evaluate the long-term safety and tolerability of lapaquistat acetate 50 mg/day.
Study Type
Interventional
Enrollment (Actual)
657
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tallinn, Estonia
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Tartu, Estonia
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Balatonfured, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Pecs, Hungary
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Szekszárd, Hungary
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Érd, Hungary
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Beer Sheva, Israel
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Hadera, Israel
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Haifa, Israel
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Jerusalem, Israel
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Kfar-Saba, Israel
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Nahariya, Israel
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Safed, Israel
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Tel Aviv, Israel
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Daugavpils, Latvia
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Kuldiga, Latvia
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Riga, Latvia
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Amsterdam, Netherlands
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Breda, Netherlands
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GA Nijmegen, Netherlands
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Groningen, Netherlands
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Hoorn, Netherlands
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Rotterdam, Netherlands
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Utrecht, Netherlands
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Zoetermeer, Netherlands
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Elverum, Norway
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Hamar, Norway
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Kongsberg, Norway
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Oslo, Norway
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Ålesund, Norway
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Moscow, Russian Federation
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Saratov, Russian Federation
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St. Petersburg, Russian Federation
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Tyumen, Russian Federation
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Volgograd, Russian Federation
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Bratislava, Slovakia
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Dolný Kubín, Slovakia
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Kosice, Slovakia
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Nitra, Slovakia
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Nové Mesto Nad Váhom, Slovakia
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Trebišov, Slovakia
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Cordoba, Spain
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Madrid, Spain
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Pontevedra, Spain
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REUS (Tarragona), Spain
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Valencia, Spain
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Dnepropetrovsk, Ukraine
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Kharkiv, Ukraine
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Kharkov, Ukraine
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Kiev, Ukraine
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Kyiv, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Belfast, United Kingdom
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Bolton, United Kingdom
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Glasgow, Scotland, United Kingdom
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Oldham, United Kingdom
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Paignton, Devon, United Kingdom
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Sheffield, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- Prior to Randomization, the participant has a mean low density lipoprotein cholesterol level greater than or equal to 130 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.
Exclusion Criteria:
- Has an nine 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 fibrates within 42 days of Visit 1 or any lipid-lowering therapy for at least 30 days prior to Screening.
- Has a previous history of cancer that has been in remission for less than 5 years prior to the first dose of study medication.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo QD
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Lapaquistat acetate placebo-matching tablets, orally, once daily for up to 12 weeks.
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Experimental: Lapaquistat Acetate 50 mg QD
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Lapaquistat acetate 50 mg, tablets, orally, once daily for up to 12 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol
Time Frame: Week 12 or Final Visit
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Week 12 or Final Visit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Change from Baseline in Triglycerides
Time Frame: Week 12 or Final Visit
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Week 12 or Final Visit
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Change from Baseline in Total Cholesterol
Time Frame: Week 12 or Final Visit
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Week 12 or Final Visit
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Change from Baseline in apolipoprotein B
Time Frame: Week 12 or Final Visit
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Week 12 or Final Visit
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Change from Baseline in non- High Density Lipoprotein cholesterol
Time Frame: Week 12 or Final Visit
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Week 12 or Final Visit
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Change from Baseline in High Density Lipoprotein cholesterol
Time Frame: Week 12 or Final Visit
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Week 12 or Final Visit
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Change from Baseline in Very Low Density Lipoprotein cholesterol
Time Frame: Week 12 or Final Visit
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Week 12 or Final Visit
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Change from Baseline in the ratio of Total Cholesterol/High Density Lipoprotein cholesterol
Time Frame: Week 12 or Final Visit
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Week 12 or Final Visit
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Change from Baseline in the ratio of apolipoprotein A1/apolipoprotein B
Time Frame: Week 12 or Final Visit
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Week 12 or Final Visit
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Change from Baseline in the ratio of Low Density Lipoprotein cholesterol/High Density Lipoprotein cholesterol
Time Frame: Week 12 or Final Visit
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Week 12 or Final Visit
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Change from Baseline in apolipoprotein A1 Timeframe: Week 12 or Final Visit
Time Frame: Week 12 or Final Visit
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Week 12 or Final Visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
September 18, 2007
First Submitted That Met QC Criteria
September 18, 2007
First Posted (Estimate)
September 20, 2007
Study Record Updates
Last Update Posted (Estimate)
May 24, 2012
Last Update Submitted That Met QC Criteria
May 23, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAK-475_306
- U1111-1122-8417 (Registry Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypercholesterolemia
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