A Placebo-controlled, Double-blind, Randomized Study to Evaluate the Efficacy and Safety of TAK-475 50 mg and 100 mg Versus Placebo, When Co-administered With Simvastatin 20 mg or 40 mg in Subjects With Primary Dyslipidemia.

NCT00256178 Phase 3 COMPLETED

The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with simvastatin on cholesterol levels in subjects with primary dyslipidemia

Details

Lead sponsor	Takeda
Phase	Phase 3
Status	COMPLETED
Enrolment	411
Start date	2005-10
Completion	2007-03

Conditions

• Hypercholesterolemia

Interventions

• Lapaquistat acetate and simvastatin
• Lapaquistat acetate and simvastatin
• Simvastatin

Primary outcomes

• Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol — Week 24 or Final Visit

Countries

Czechia, Estonia, Finland, Germany, Poland, South Africa, United Kingdom