A Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 100 mg and Lapaquistat Acetate 100 mg Administered in Combination With Ezetimibe 10 mg vs Ezetimibe 10 mg in Subjects With Primary Dyslipidemia

NCT00268697 Phase 3 COMPLETED

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

Details

Lead sponsor	Takeda
Phase	Phase 3
Status	COMPLETED
Enrolment	1267
Start date	2005-10
Completion	2007-01

Conditions

• Hypercholesterolemia

Interventions

• Lapaquistat acetate
• Lapaquistat acetate and ezetimibe
• Ezetimibe

Primary outcomes

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

Countries

Estonia, Latvia, Russia, Serbia