Efficacy of Lapaquistat Acetate and Simvastatin in Subjects With Primary Dyslipidemia.
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.
3 other identifiers
interventional
411
7 countries
53
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2005
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 16, 2005
CompletedFirst Posted
Study publicly available on registry
November 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedMay 24, 2012
May 1, 2012
1.4 years
November 16, 2005
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol
Week 24 or Final Visit
Secondary Outcomes (20)
Change from Baseline in Triglycerides
Week 24 or Final Visit
Change from Baseline in Total Cholesterol
Week 24 or Final Visit
Change from Baseline in High Density Lipoprotein cholesterol
Week 24 or Final Visit
Change from Baseline in Very Low Density Lipoprotein cholesterol
Week 24 or Final Visit
Change from Baseline in apolipoprotein A1
Week 24 or Final Visit
- +15 more secondary outcomes
Study Arms (3)
Lapaquistat Acetate 50 mg QD + Simvastatin
EXPERIMENTALLapaquistat Acetate 100 mg QD + Simvastatin
EXPERIMENTALSimvastatin
ACTIVE COMPARATORInterventions
Lapaquistat acetate 50 mg, tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks.
Lapaquistat acetate placebo-matching tablets, orally, once daily and stable simvastatin therapy for up to 24 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.
- 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.
You may not qualify if:
- 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.
- 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 (53)
Unknown Facility
Benešov, Czechia
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Holice V Čechách, Czechia
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Kladno, Czechia
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Mladá Boleslav, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Trutnov, Czechia
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ĂšstĂ nad OrlicĂ, Czechia
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ZlĂn, Czechia
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Pärnu, Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Aura, Finland
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Helsinki, Finland
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Hyvinkää, Finland
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Oulu, Finland
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Tampere, Finland
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Turku, Finland
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Berlin, Germany
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Bochum, Germany
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Chemnitz, Germany
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Dresden, Germany
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Frankfurt, Germany
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Görlitz, Germany
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Leipzig, Germany
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Nuremberg, Germany
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Krakow, Poland
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Lublin, Poland
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Niemodlin, Poland
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Skierniewice, Poland
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Sroda Wlkp., Poland
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Starachowice, Poland
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Swietokrzyski, Poland
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Warsaw, Poland
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Zakopane, Poland
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Bloemfontein, South Africa
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Cape Town, South Africa
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Johannesburg, South Africa
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Pretoria, South Africa
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Randburg, South Africa
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Tongaat, South Africa
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Bath, United Kingdom
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Birmingham, United Kingdom
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Blackpool, United Kingdom
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Blantyre, United Kingdom
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Chippenham, United Kingdom
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Eastwood, United Kingdom
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Glasgow, United Kingdom
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Harrow, United Kingdom
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Hinckley, United Kingdom
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Newport Isle of Wight, United Kingdom
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Nottingham, United Kingdom
Unknown Facility
Woolpit, United Kingdom
Related Publications (1)
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.
PMID: 21518985RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
November 16, 2005
First Posted
November 21, 2005
Study Start
October 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
May 24, 2012
Record last verified: 2012-05