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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00532311 |
The purpose of the study is to determine the efficacy of lapaquistat taken with statins on cholesterol levels in subjects with hypercholesterolemia
Condition | Intervention | Phase |
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Hypercholesterolemia |
Drug: Lapaquistat and stable statin therapy Drug: Stable statin therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 50 mg or Placebo When Co-Administered With Statins in Subjects With Hypercholesterolemia, With an Optional Open-Label Extension |
Enrollment: | 411 |
Study Start Date: | July 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Lapaquistat and stable statin therapy
Lapaquistat 50 mg, tablets, orally, once daily and stable statin therapy for up to 12 weeks.
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2: Placebo Comparator |
Drug: Stable statin therapy
Lapaquistat placebo-matching tablets, orally, once daily and stable statin therapy for up to 12 weeks.
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Dyslipidemias are a group of metabolic disorders produced by raised concentrations of lipoproteins, especially low-density lipoprotein cholesterol, which is the lipoprotein that transports endogenous cholesterol from the liver to the peripheral tissues. Increased cholesterol and triglycerides levels lead to an increased risk of arteriosclerosis, which is the underlying cause of heart attack, strokes and peripheral vascular disease.
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 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Medical Director | Takeda Global Research & Development Center, Inc. |
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | TAK-475-307 |
Study First Received: | September 18, 2007 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00532311 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hyperlipidemia Drug Therapy |
Antimetabolites Hyperlipidemias Metabolic Diseases Simvastatin Antilipemic Agents Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Fluvastatin |
Pravastatin Rosuvastatin Hypercholesterolemia Metabolic Disorder Dyslipidemias Atorvastatin Lovastatin Lipid Metabolism Disorders |
Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Pravastatin Therapeutic Uses Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |