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Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)

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: NCT00651274
Recruitment Status : Completed
First Posted : April 2, 2008
Last Update Posted : May 11, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in further reducing LDL-C concentrations.

Condition or disease Intervention/treatment Phase
Atherosclerosis Hypercholesterolemia Coronary Heart Disease Drug: Ezetimibe Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
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 Co-administration Of Ezetimibe 10 Mg Or Ezetimibe Placebo To Ongoing Treatment With Simvastatin 20 Mg In Subjects With Primary Hypercholesterolemia And Coronary Heart Disease
Actual Study Start Date : April 1, 2003
Actual Primary Completion Date : August 1, 2004
Actual Study Completion Date : August 1, 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ezetimibe Drug: Ezetimibe
oral tablets: ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)
Other Name: SCH 58235

Placebo Comparator: Placebo Drug: Placebo
oral tablets: placebo to match ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)

Primary Outcome Measures :
  1. Percent change from baseline in LDL-cholesterol with ezetimibe added to simvastatin versus continued simvastatin alone. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Percentage of subjects who achieve target LDL-C as defined by the ESC or NCEP guidelines with ezetimibe added to simvastatin versus continued simvastatin alone [ Time Frame: 6 weeks ]
  2. Percent change from baseline in total cholesterol, HDL-C and triglycerides with ezetimibe added to simvastatin versus continued simvastatin alone. [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
  • Subjects must be >= 18 years and <= 75 years of age.
  • Subjects must have an LDL-C concentration >= 2.6 mmol/L (100 mg/dL) to <= 4.1 mmol/L (160 mg/dL) using the Friedewald calculation available at the time of randomization Visit 3 (Baseline Visit).
  • Subjects must have triglyceride concentrations of < 3.99 mmol/L (350 mg/dL) at Visit 3 (Baseline Visit).
  • Subjects must have documented coronary heart disease (CHD). For the purposes of this study, CHD will include one or more of the following features: documented stable angina (with evidence of ischemia on exercise testing); history of myocardial infarction; history of percutaneous coronary intervention (primarily PTCA with or without stent placement); symptomatic peripheral vascular disease (claudication); documented history of atherothrombotic cerebrovascular disease; and/or documented history of unstable angina or non-Q wave myocardial infarction.
  • Subject must be currently taking simvastatin 20 mg daily and by history has taken 80% of daily evening doses for the preceding 6 weeks prior to Visit 3 (Baseline Visit).
  • Subjects must have liver transaminases (ALT, AST) < 50% above the upper limit of normal, with no active liver disease, and CK < 50% above the upper limit of normal at Visit 3 (Baseline Visit).
  • Clinical laboratory tests (CBC, blood chemistries, urinalysis) must be within normal limits or clinically acceptable to the investigator at Visit 3 (Baseline Visit).
  • Subjects must have maintained a cholesterol lowering diet program for at least 4 weeks prior to the study and be willing to continue the same diet program during the study.
  • Subjects must report a stable weight history for at least 4 weeks prior to entry into study at Visit 3 (Baseline Visit).
  • Women receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose and regimen for at least 8 weeks and be willing to continue the same regimen for the duration of the study.
  • Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
  • Subjects must be free of any clinically significant diseases other than hyperlipidemia or coronary heart disease that would interfere with study evaluations.
  • Subjects must understand and be able to adhere to the dosing and visit schedules, and must agree to remain on their cholesterol-lowering diet and their exercise regimen for the duration of the study.

Exclusion Criteria:

  • Subjects whose body mass index (BMI) is >= 30 Kg/m^2 at Visit 3 (Baseline Visit).
  • Subjects who consume > 14 alcoholic drinks per week. (A drink is: a can of beer, glass of wine, or single measure of spirits).
  • Any condition or situation which, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.
  • Women who are pregnant or nursing.
  • Subjects who have not observed the designated washout periods for any of the prohibited medications
Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00651274    
Other Study ID Numbers: P03476
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents