Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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 Frosst Canada Ltd.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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
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
Study Start Date : January 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Arm Intervention/treatment
Experimental: Ezetimibe Drug: Ezetimibe
oral tablet; ezetimibe 10 mg once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)
Other Names:
  • SCH 58235
  • Zetia
Placebo Comparator: Placebo Drug: Placebo
oral tablet; ezetimibe placebo once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)

Primary Outcome Measures :
  1. Percentage of patients reaching LDL-C goal of < 2.5 mmol/L (97 mg/dL) at endpoint. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Percent change from baseline to endpoint in LDL-C. [ Time Frame: 6 weeks ]
  2. 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 ]
  3. Safety/tolerability: adverse events, laboratory test results, vital signs. [ Time Frame: Throughout study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • >=18 years of age and treated with simvastatin 10 mg or 20 mg for at least 6 weeks and LDL-C levels of > 2.5 mmol/L to <=4.20 mmol/L (97 mg/dL to 160 mg/dL) at Visit 1.
  • history of coronary heart disease (type II diabetic patients > 30 years old with no CHD)
  • triglycerides <= 4.00 mmol/L drawn, and liver transaminases (ALT, AST) <=50% above the upper limit of normal at Visit 2, with no active liver disease, and/or creatine kinase (CK) <=50% above the upper limit of normal

Exclusion Criteria:

  • subjects with Body Mass Index >=35 kg/sqm at Visit 1
  • alcohol consumption > 14 drinks per week
  • pregnant or lactating
  • treated with any other investigational drug within 30 days prior Visit 1
  • previously treated with ezetimibe or participated in a clinical study with ezetimibe
  • any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00651014     History of Changes
Other Study ID Numbers: P03405
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors