Efficacy of Lapaquistat Acetate Co-Administered With Statins in Subjects With Hypercholesterolemia
NCT ID: NCT00532311
Last Updated: 2016-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
411 participants
INTERVENTIONAL
2007-07-31
2008-04-30
Brief Summary
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Detailed Description
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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.
This study will evaluate the efficacy and safety of lapaquistat acetate taken with either torvastatin, simvastatin, rosuvastatin, pravastatin, fluvastatin or lovastatin (stable statin therapy) in subjects with hypercholesterolemia. Total participation time in this study is expected to be up to 12 weeks, with an optional, 48-week, open-label extension period for participants who qualify.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lapaquistat Acetate 50 mg QD
(and stable statin therapy)
Lapaquistat acetate and stable statin therapy
Lapaquistat acetate 50 mg, tablets, orally, once daily and stable statin therapy for up to 12 weeks.
Stable statin therapy
Stable statin therapy
Lapaquistat acetate placebo-matching tablets, orally, once daily and stable statin therapy for up to 12 weeks.
Interventions
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Lapaquistat acetate and stable statin therapy
Lapaquistat acetate 50 mg, tablets, orally, once daily and stable statin therapy for up to 12 weeks.
Stable statin therapy
Lapaquistat acetate placebo-matching tablets, orally, once daily and stable statin therapy for up to 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has been on a stable dose of statin for at least 3 months prior to Screening. Participants enrolled in Canada, Latin America, and South Africa must be on the maximum approved dose of statin (atorvastatin 80 mg, simvastatin 80 mg, rosuvastatin 40 mg, pravastatin 80 mg, fluvastatin 80 mg, or lovastatin 80 mg).
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Birmingham, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Tuscaloosa, Alabama, United States
Chandler, Arizona, United States
Gilbert, Arizona, United States
Glendale, Arizona, United States
Tucson, Arizona, United States
Artesia, California, United States
Long Beach, California, United States
Santa Ana, California, United States
Santa Rosa, California, United States
Tustin, California, United States
Walnut Creek, California, United States
Colorado Springs, Colorado, United States
Golden, Colorado, United States
Washington D.C., District of Columbia, United States
Coral Gables, Florida, United States
Fort Meyers, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Pembroke Pines, Florida, United States
Pensacola, Florida, United States
Pinellas Park, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
Dunwoody, Georgia, United States
Idaho Falls, Idaho, United States
Aurora, Illinois, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
CantonAuburn, Maine, United States
Scarborough, Maine, United States
Baltimore, Maryland, United States
Haverhill, Massachusetts, United States
Ann Arbor, Michigan, United States
Brooklyn Center, Minnesota, United States
Edina, Minnesota, United States
Olive Branch, Mississippi, United States
St Louis, Missouri, United States
Billings, Montana, United States
Margate City, New Jersey, United States
Wilwood, New Jersey, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Statesville, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Kettering, Ohio, United States
Mentor, Ohio, United States
Zanesville, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Altoona, Pennsylvania, United States
Dowington, Pennsylvania, United States
Sellerville, Pennsylvania, United States
Warwick, Rhode Island, United States
Goose Creek, South Carolina, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
Bristol, Tennessee, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Burke, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Wauwatosa, Wisconsin, United States
Countries
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Other Identifiers
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U1111-1122-8479
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-475_307
Identifier Type: -
Identifier Source: org_study_id
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