Ezetimibe Plus Atorvastatin Versus Atorvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03406)

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: NCT00651404
Recruitment Status : Completed
First Posted : April 2, 2008
Last Update Posted : April 8, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
To compare the efficacy of ezetimibe 10 mg added daily to ongoing treatment with atorvastatin 10 mg daily versus ezetimibe placebo added daily to ongoing treatment with atorvastatin 10 mg daily in reducing the concentration of LDL-cholesterol (LDL-C) at endpoint after 6 weeks of treatment.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Atherosclerosis Drug: Ezetimibe Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 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 Atorvastatin 10 mg In Subjects With Primary Hypercholesterolemia And Coronary Heart Disease.
Study Start Date : January 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Arm Intervention/treatment
Experimental: Ezetimibe Drug: Ezetimibe
oral tablets; ezetimibe 10 mg daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily)
Other Names:
  • SCH 058235
  • Zetia

Placebo Comparator: Placebo Drug: Placebo
oral tablet; ezetimibe placebo daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily)

Primary Outcome Measures :
  1. Percent change from baseline to end of treatment in LDL-C. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Percent of subjects who achieve the target LDL-C goal as defined by the ESC/NCEP guidelines. [ Time Frame: 6 weeks ]
  2. Percent change from baseline to end of treatment in total cholesterol, HDL-C and triglycerides. [ Time Frame: 6 weeks ]
  3. Safety/tolerability: adverse events, laboratory test results, vital signs, physical examinations. [ Time Frame: Throughout study ]

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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:

  • >=18 years and <= 75 years of age with 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) and triglyceride concentrations of < 3.99 mmol/L (350 mg/dL) at Baseline Visit
  • documented coronary heart disease
  • currently taking atorvastatin 10 mg daily and history has taken 80 % of daily doses for the preceding 6 weeks prior to Visit 3
  • 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 Baseline Visit.
  • cholesterol lowering diet and exercise program for at least 4 weeks prior to and during the study, and stable weight history.
  • 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 continue same regimen during the study.
  • women of non-childbearing potential or using acceptable method of birth control.
  • subjects must be free of any clinically significant diseases other than hyperlipidemia or coronary heart disease that would interfere with study evaluations.

Exclusion Criteria:

  • Subjects whose body mass index is >=30 kg/sqm at baseline.
  • Subjects who consume >14 alcoholic drinks per week.
  • Any condition or situation that, 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 designated washout periods for prohibited medications (eg, potent inhibitors of CYP3A4, prescription or over-the-counter agents know to lower lipid levels, corticosteroids), or have been on a stable regimen of any cardiovascular agent for <6 weeks.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00651404     History of Changes
Other Study ID Numbers: P03406
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

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