Efficacy of Lapaquistat Acetate in Subjects With Hypercholesterolemia

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

The purpose of this study is to determine the role of time of dosing on the lipid-lowering effects of lapaquistat acetate, once daily (QD) or twice daily (BID), in subjects with hypercholesterolemia.

Key facts

Study ID

NCT00865228

Run by

Takeda

People needed

224

Starts

2007-07-01

Expected to finish

2007-11-01

Last updated by the study team

2012-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
• Has prior to Randomization a mean low-density lipoprotein cholesterol greater than or equal to 130 mg/dL and less than or equal to 220 mg/dL for 2 consecutive samples.
• Has prior to Randomization mean triglycerides less than 400 mg/dL for 2 consecutive samples.
• Is willing and able to comply with a standardized, therapeutic lifestyle change diet or equivalent.

You may not qualify if…

• Has an alanine aminotransferase or aspartate aminotransferase level greater than 2 times the upper limit of normal during the screening period.
• Has a serum creatinine greater than133 mmol/L during the screening period.
• Has a creatine phosphokinase greater than 3 times the upper limit of normal, identified during the screening period.
• Has active liver disease or jaundice.
• Has a 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 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, abdomin al aorticaneurysm, coronary angioplasty, coronary or peripheral arterial surgery or multiple risk factors that confer a 10-year risk for cardiovascular 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 is taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
• Has received any investigational compound within 30 days prior to screening Visit 1, or is currently participating in another 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.
• Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.
• Has uncontrolled hypertension despite treatment at Screening Visit 1.
• Has had inflammatory bowel 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 alcohol abuse within the past 2 years.
• Has stage I squamous cell carcinoma of the skin.
• Has type 1 or type 2 diabetes mellitus.
• Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
• Fluvastatin
• Lovastatin
• bile acid sequestrants (eg, cholestyramine)
• intestinal cholesterol uptake inhibitors (eg, ezetimibe)
• Fibrates (eg, fenofibrate, gemfibrozil)

Where it is running

• Study site — Long Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Wichita, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Margate City, New Jersey, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Statesville, North Carolina, United States
• Study site — Wilmington, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Medford, Oregon, United States
• Study site — Perkasie, Pennsylvania, United States
• Study site — Sellerville, Pennsylvania, United States
• Study site — Bristol, Tennessee, United States
• Study site — Norfolk, Virginia, United States
• Study site — Richmond, Virginia, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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