Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)
This study has been terminated.
(slow subject recruitment and lack of medical and scientific merit due to change in new standard of therapy during that same period.)
Merck Sharp & Dohme Corp.
First Posted: April 2, 2008
Last Update Posted: April 16, 2015
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
The study was designed to assess whether 6 weeks of co-administration of ezetimibe and simvastatin is more effective than simvastatin monotherapy in allowing patients in the CHD risk strata of the NCEP III guidelines to achieve their LDL-C target goal of <=3.0 mmol/L. As this study was to be conducted in Canada, the target LDL-C goal for patients with CHD, or type II diabetic patients >30 years old with no CHD, was <2.5 mmol/L.
|Hypercholesterolemia Atherosclerosis||Drug: Ezetimibe Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 10mg or 20mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease and/or Type II Diabetes|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Percentage of patients reaching LDL-C goal of < 2.5 mmol/L (97 mg/dL) at endpoint. [ Time Frame: 6 weeks ]
Secondary Outcome Measures:
- Percent change from baseline to endpoint in LDL-C. [ Time Frame: 6 weeks ]
- Percent change from baseline to endpoint in total cholesterol (TC) triglycerides, HDL-C, non-HDL-C, LDL-C/HDL-C ratio, TC/HDL-C ratio, and apolipoprotein B. [ Time Frame: 6 weeks ]
- Safety/tolerability: adverse events, laboratory test results, vital signs. [ Time Frame: Throughout study ]
|Study Start Date:||January 2004|
|Study Completion Date:||June 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
oral tablet; ezetimibe 10 mg once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)
|Placebo Comparator: Placebo||
oral tablet; ezetimibe placebo once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)
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