Study Stopped
Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents
Efficacy of Lapaquistat Acetate on Blood Cholesterol Levels in Treating Subjects With Hypercholesterolemia
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
2 other identifiers
interventional
657
10 countries
55
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2007
Shorter than P25 for phase_3
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2007
CompletedFirst Posted
Study publicly available on registry
September 20, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMay 24, 2012
May 1, 2012
7 months
September 18, 2007
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol
Week 12 or Final Visit
Secondary Outcomes (10)
Change from Baseline in Total Cholesterol
Week 12 or Final Visit
Change from Baseline in High Density Lipoprotein cholesterol
Week 12 or Final Visit
Change from Baseline in Very Low Density Lipoprotein cholesterol
Week 12 or Final Visit
Change from Baseline in apolipoprotein A1 Timeframe: Week 12 or Final Visit
Week 12 or Final Visit
Change from Baseline in apolipoprotein B
Week 12 or Final Visit
- +5 more secondary outcomes
Study Arms (2)
Lapaquistat Acetate 50 mg QD
EXPERIMENTALPlacebo QD
PLACEBO COMPARATORInterventions
Lapaquistat acetate 50 mg, tablets, orally, once daily for up to 12 weeks.
Lapaquistat acetate placebo-matching tablets, orally, once daily for up to 12 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (60)
Unknown Facility
Tallinn, Estonia
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Tartu, Estonia
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Balatonfüred, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Érd, Hungary
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Pécs, Hungary
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Szekszárd, Hungary
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Beersheba, 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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Kuldīga, 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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Ålesund, Norway
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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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Moscow, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Tyumen, Russia
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Volgograd, Russia
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Bratislava, Slovakia
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Dolný Kubín, Slovakia
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Košice, 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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Córdoba, 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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Dnipro, Ukraine
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Kharkiv, 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
Unknown Facility
Sheffield, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2007
First Posted
September 20, 2007
Study Start
October 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
May 24, 2012
Record last verified: 2012-05