Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)
|ClinicalTrials.gov Identifier: NCT00651014|
Recruitment Status : Terminated (slow subject recruitment and lack of medical and scientific merit due to change in new standard of therapy during that same period.)
First Posted : April 2, 2008
Last Update Posted : April 16, 2015
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia Atherosclerosis||Drug: Ezetimibe Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||January 2004|
|Primary Completion Date :||June 2006|
|Study Completion Date :||June 2006|
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)
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 ]
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