Efficacy of Lapaquistat Acetate Alone or Combined With High-Dose Statin Therapy in Subjects With Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title: A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat or Placebo When Co-Administered With High Dose Statin Therapy in Subjects With Primary Hypercholesterolemia

Status Terminated

Clinical Trial Summary

The purpose of this study is to evaluate lapaquistat acetate, once daily (QD), taken alone or with additional statin therapy on cholesterol levels in treating patients with elevated cholesterol.

Clinical Trial Description

Elevated plasma cholesterol (hypercholesterolemia) and various other plasma lipid imbalances (dyslipidemias) are major risk factors for coronary heart disease. Patients with hypercholesterolemia have elevated low-density lipoprotein cholesterol, which leads to atherosclerotic deposition of cholesterol in the arterial walls. As identified by the National Cholesterol Education Program Adult Treatment Panel III, lowering the low-density lipoprotein cholesterol plasma concentration effectively reduces cardiovascular morbidity and mortality and is essential for the prevention and management of coronary heart disease.

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 atorvastatin, rosuvastatin or simvastatin (stable statin therapy) will be more efficacious in lowering low-density lipoprotein cholesterol, compared to lapaquistat or stable statin therapy alone. Total participation time in this study is anticipated to be 24 weeks. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

• NCT number: NCT00249899
• Study type: Interventional
• Source: Takeda
• Status: Terminated
• Phase: Phase 3
• Start date: November 2005
• Completion date: March 2007