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Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)

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: NCT00653835
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : May 11, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C concentrations when administered for 6 weeks.

Condition or disease Intervention/treatment Phase
Hypercholesterolaemia Atherosclerosis Drug: Ezetimibe + Simvastatin Drug: Simvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SCH 58235: A Multicenter, Randomised, Parallel Groups, Placebo-Controlled Study Comparing The Efficacy, Safety, and Tolerability Of The Daily Co-Administration of Ezetimibe 10 mg With Simvastatin 20 mg vs Ezetimibe Placebo With Simvastatin 20 mg in Untreated Subjects With Primary Hypercholesterolaemia And Coronary Heart Disease (Protocol P03435)
Actual Study Start Date : September 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 + Simvastatin Drug: Ezetimibe + Simvastatin
oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks
Other Names:
  • SCH 58235
  • Zetia
  • Zocor

Active Comparator: Simvastatin Drug: Simvastatin
oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks
Other Name: Zocor

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

Secondary Outcome Measures :
  1. Percent of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint. [ Time Frame: 6 weeks ]
  2. Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides. [ Time Frame: 6 weeks ]
  3. Safety: adverse events, laboratory test results, vital signs. [ Time Frame: Throughout study ]

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:

  • >=18 years and <= 75 years of age
  • LDL-C concentration >= 3.3 mmol/L (130 mg/dL) to <= 4.9 mmol/L (190 mg/dL) at baseline.
  • Triglyceride concentration <3.99 mmol/L (350 mg/dL) at baseline.
  • Documented coronary heart disease (CHD), which will include one or more of the following features: documented stable angina (with evidence of ischemia on exercise testing); history of MI; history of PCI (primarily PTCA with or without stent replacement); symptomatic peripheral vascular disease; documented history of atherothrombotic cerebrovascular disease; and/or documented history of non-Q wave MI.
  • Stable weight history for at least 4 weeks prior to entry into study at baseline.
  • Female subjects of childbearing potential must be using an acceptable method of birth control or be surgically sterilized.

Exclusion Criteria:

  • Body mass index (BMI) >=35 kg/m^2 at baseline.
  • Subjects whose liver transaminases (ALT, AST) are >1.5 times the upper limit of normal and with active liver diseases at baseline.
  • Subjects with evidence of current myopathy (including subjects with CK>1.5 times above the upper limit of normal) at baseline.
  • Subjects with clinical laboratory tests (CBC, blood chemistries, urinalysis) outside the normal range that are clinically acceptable to the investigator at baseline.
  • Subjects with Type II diabetes mellitus who are poorly controlled (HbA1c>9%) or newly diagnosed (within 3 months) or who have had a change in anti-diabetic therapy within 3 months of baseline.
  • Subjects with Type I diabetes mellitus who have not been on a stable insulin regimen for 3 months prior to baseline, or who have a recent history of repeated hypoglycaemia or unstable glycaemic control.
  • Subjects who have known hypersensitivity to HMG-CoA reductase inhibitors.
  • Female subjects who consume >14 units and male subjects who consume >21 units of alcohol per week.
  • Female subjects who are pregnant or breast feeding.
  • 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: NCT00653835    
Other Study ID Numbers: P03435
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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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