Efficacy of Lapaquistat Acetate Alone or Combined With Rosuvastatin in Subjects With Hypercholesterolemia
NCT ID: NCT00249912
Last Updated: 2012-05-24
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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COMPLETED
PHASE3
415 participants
INTERVENTIONAL
2005-10-31
2007-04-30
Brief Summary
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Detailed Description
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Currently, 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) are the first-line monotherapies prescribed to reduce low-density lipoprotein cholesterol, after diet and therapeutic lifestyle change. However, low doses of statins often fail to produce the ATP III-recommended levels of low-density lipoprotein cholesterol reduction, making it necessary to increase the dose or add an additional treatment. Dose increases of statins in turn may result in decreased tolerability and potential safety concerns which contribute to the high discontinuation rates of statins and their prescription at low, and often ineffective, doses.
The purpose of this study is to determine whether administration of lapaquistat acetate co-administered with rosuvastatin will be more efficacious in lowering low-density lipoprotein cholesterol, compared to lapaquistat or rosuvastatin alone. Total participation time in this study is anticipated to be 24 weeks.
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 + Rosuvastatin
Lapaquistat acetate and rosuvastatin
Lapaquistat acetate 50 mg, tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
Lapaquistat Acetate 100 mg QD + Rosuvastatin
Lapaquistat acetate and rosuvastatin
Lapaquistat acetate 100 mg, tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
Rosuvastatin
Rosuvastatin
Lapaquistat acetate placebo-matching tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
Interventions
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Lapaquistat acetate and rosuvastatin
Lapaquistat acetate 50 mg, tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
Lapaquistat acetate and rosuvastatin
Lapaquistat acetate 100 mg, tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
Rosuvastatin
Lapaquistat acetate placebo-matching tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Participant is taking a stable dose of rosuvastatin (10 or 20 mg) for at least 4 weeks prior to Screening.
Exclusion Criteria
* 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.
* The subject had a known hypersensitivity or history of adverse reaction rosuvastatin.
* 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
* Has inflammatory bowel disease, any other malabsorption syndrome, or had gastric bypass or any other surgical procedure for weight loss.
* Is unwilling or unable, in the opinion of the investigator, to comply with the protocol or scheduled appointments.
* Has a history of drug abuse or a history of alcohol abuse within the past 2 years.
* Has any other serious disease or condition that might reduced life expectancy, impaired successful management according to the protocol, or make the participant an unsuitable candidate to receive study medication.
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
Haleyville, Alabama, United States
Mobile, Alabama, United States
Scottsdale, Arizona, United States
Long Beach, California, United States
Mission Viejo, California, United States
Orange, California, United States
Redondo Beach, California, United States
Rolling Hills Estates, California, United States
San Diego, California, United States
Torrance, California, United States
Tustin, California, United States
Avon, Connecticut, United States
Bristol, Connecticut, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Ocala, Florida, United States
Pembroke Pines, Florida, United States
Plantation, Florida, United States
Hayden Lake, Idaho, United States
Meridian, Idaho, United States
Arlington Heights, Illinois, United States
Aurora, Illinois, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Witchita, Kansas, United States
Louisville, Kentucky, United States
Thibodaux, Louisiana, United States
Auburn, Maine, United States
Haverhill, Massachusetts, United States
Benzonia, Michigan, United States
Detroit, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Concord, New Hampshire, United States
West Seneca, New York, United States
Raleigh, North Carolina, United States
Statesville, North Carolina, United States
Winstom-Salem, North Carolina, United States
Grand Forks, North Dakota, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Kettering, Ohio, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Lansdale, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Scotland, Pennsylvania, United States
Cranston, Rhode Island, United States
Anderson, South Carolina, United States
Bristol, Tennessee, United States
Cordova, Tennessee, United States
Kingsport, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
McKinney, Texas, United States
Midland, 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
Weber City, Virginia, United States
Bellevue, Washington, United States
Burien, Washington, United States
Edmonds, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Calgary, Alberta, Canada
Portage la Prairie, Manitoba, Canada
London, Ontario, Canada
Oakville, Ontario, Canada
Oshawa, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Saint-Jérôme, Quebec, Canada
Ste-Foy, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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U1111-1122-8106
Identifier Type: REGISTRY
Identifier Source: secondary_id
01-05-TL-475-022
Identifier Type: -
Identifier Source: org_study_id
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