Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With Primary Hypercholesterolemia and Coronary Heart Disease (P03396)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: April 2, 2008
Last Update Posted: July 7, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
The primary objective is to evaluate the efficacy and safety of coadministration of ezetimibe 10 mg with atorvastatin 10 mg in untreated subjects with primary hypercholesterolemia and coronary heart disease for whom diet and exercise have failed. The primary variable is LDL-cholesterol (LDL-C), and the secondary variable is total cholesterol (TC), HDL-C, and triglycerides (TG). The following variables were used to assess the safety and compliance of the drug: vital signs and laboratory values. Variables were measured before the first administration of the drug and at the last administration of the drug, after 6 weeks of treatment. Adverse events were also assessed.
|Hypercholesterolemia Atherosclerosis Coronary Artery Disease||Drug: Ezetimibe + Atorvastatin Drug: Atorvastatin||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Parallel Groups, Placebo-controlled Study Comparing the Efficacy, Safety, and Tolerability of the Daily Coadministration of Ezetimibe 10 mg With Atorvastatin 10 mg in Untreated Subjects With Primary Hypercholesterolemia and Coronary Heart Disease for Whom Diet and Exercise Have Failed.|
Resource links provided by NLM:
Drug Information available for: Atorvastatin Atorvastatin calcium Ezetimibe Atorvastatin calcium trihydrateU.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Change from baseline to endpoint in LDL-C. [ Time Frame: 6 weeks ]
Secondary Outcome Measures:
- Change from baseline to endpoint in total cholesterol, HDL-C, and triglycerides. [ Time Frame: 6 weeks ]
- Safety/tolerability: adverse events, laboratory test results, vital signs [ Time Frame: Throughout study ]
|Study Start Date:||May 2003|
|Study Completion Date:||December 2004|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
|Experimental: Ezetimibe + Atorvastatin||
Drug: Ezetimibe + Atorvastatin
oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks
|Active Comparator: Atorvastatin||
oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks
Other Name: Lipitor
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