Efficacy of Lapaquistat Acetate Alone or Combined With Simvastatin in Subjects With Hypercholesterolemia
A Double-Blind, Randomized, Placebo-Controlled Factorial Study to Evaluate the Efficacy and Safety of Lapaquistat and Simvastatin Alone and in Combination in Subjects With Hypercholesterolemia
2 other identifiers
interventional
1,362
2 countries
67
Brief Summary
The purpose of this study is to evaluate lapaquistat acetate, once daily (QD), taken alone or with simvastatin on cholesterol levels in treating patients with elevated cholesterol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2006
Shorter than P25 for phase_3
67 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
February 1, 2006
CompletedFirst Posted
Study publicly available on registry
February 3, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMay 24, 2012
May 1, 2012
1.2 years
February 1, 2006
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Low Density Lipoprotein cholesterol
Week 12 or Final Visit
Secondary Outcomes (20)
Adverse Events
Weeks: 2, 4, 8, and 12 or Final Visit
Physical Examination
Week 12 or Final Visit
Safety Laboratory Tests
Weeks: 2, 4, 8, and 12 or Final Visit
12- lead Electrocardiogram assessments
Week 12 or Final Visit
Best Corrected Visual Acuity results
Week 12 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 dose of simvastatin for up to 12 weeks.
Lapaquistat acetate placebo-matching tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks.
Eligibility Criteria
You may qualify if:
- Woman of childbearing potential can not to be pregnant, lactating, not planning on becoming pregnant, and agree to use acceptable forms of contraception throughout the course of the study.
- Prior to Randomization, has a low-density lipoprotein cholesterol level mean greater than or equal to 3.37 mmol/L and less than or equal to 5.70 mmol/L.
- Prior to Randomization, has a mean triglyceride level less than or equal to 4.52 mmol/L (400 mg/dL).
- Has clinical laboratory evaluations including clinical chemistry, hematology, and urinalysis within the defined reference range.
You may not qualify if:
- Has an alanine aminotransferase or aspartate aminotransferase level of greater than 1.5 times the upper limit of normal, active liver disease or jaundice.
- Has a serum creatinine of greater than 133 μmol/L.
- Has a creatine kinase greater than 3 times the upper limit of normal.
- Has type 1 or 2 diabetes mellitus.
- Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication.
- Has an endocrine disorder, such as Cushing syndrome, hyperthyroidism, or inappropriately treated hypothyroidism, affecting lipid metabolism.
- Has a history of myocardial infarction, angina pectoris, transient ischemic attacks, cerebrovascular accident, peripheral vascular disease, abdominal aortic aneurysm, coronary revascularization or multiple factors that conferred a 10-year risk for coronary heart disease greater than 20% based on Framingham risk scoring.
- Has a positive hepatitis B surface antigen, or antibody to hepatitis C virus, as determined by medical history and/or subject's verbal report.
- Has a positive human immunodeficiency virus status or was taking antiretroviral medications, as determined by medical history.
- Has exposure to lapaquistat acetate in other studies, was participating in another investigational study, or had participated in an investigational study within the past 30 days or, for drugs with a long half-life, within a period of less than 5 times the drug's half-life. Has a known hypersensitivity or history of adverse reaction to simvastatin.
- Has a known hypersensitivity or history of adverse reaction to simvastatin.
- Has a history or presence of clinically significant food allergy that would prevent adherence to the recommended 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (67)
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Chandler, Arizona, United States
Unknown Facility
Scottsdale, Arizona, United States
Unknown Facility
Sierra Vista, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Spring Valley, California, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Hollywood, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Jupiter, Florida, United States
Unknown Facility
Kissimmee, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Pinellas Park, Florida, United States
Unknown Facility
Stuart, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Arlington Heights, Illinois, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Peoria, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Edina, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Margate City, New Jersey, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Statesville, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Kettering, Ohio, United States
Unknown Facility
Bartlesville, Oklahoma, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Beaver, Pennsylvania, United States
Unknown Facility
Downingtown, Pennsylvania, United States
Unknown Facility
Tipton, Pennsylvania, United States
Unknown Facility
Goose Creek, South Carolina, United States
Unknown Facility
Jackson, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Lakewood, Washington, United States
Unknown Facility
Abbotsford, British Columbia, Canada
Unknown Facility
Coquitlam, British Columbia, Canada
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Winnipeg, Manitoba, Canada
Unknown Facility
Mount Pearl, Newfoundland and Labrador, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, Canada
Unknown Facility
Cornwall, Ontario, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Oakville, Ontario, Canada
Unknown Facility
Oshawa, Ontario, Canada
Unknown Facility
Thornhill, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Cornwall, Prince Edward Island, Canada
Unknown Facility
Mirabel, Quebec, Canada
Unknown Facility
Saint-Lambert, Quebec, Canada
Unknown Facility
Sherbrooke, Quebec, Canada
Unknown Facility
Ste-Foy, Quebec, Canada
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
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2006
First Posted
February 3, 2006
Study Start
March 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
May 24, 2012
Record last verified: 2012-05