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

Organon and Co (Industry)
Overall Status
CT.gov ID
Merck Sharp & Dohme LLC (Industry)

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Actual Enrollment :
153 participants
Intervention Model:
Parallel Assignment
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
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 :
Sep 1, 2003
Actual Primary Completion Date :
Aug 1, 2004
Actual Study Completion Date :
Aug 1, 2004

Arms and Interventions

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 Names:
  • Zocor
  • Outcome Measures

    Primary Outcome Measures

    1. Percent change in LDL-C from baseline to endpoint. [6 weeks]

    Secondary Outcome Measures

    1. Percent of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint. [6 weeks]

    2. Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides. [6 weeks]

    3. Safety: adverse events, laboratory test results, vital signs. [Throughout study]

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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.

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Organon and Co
    • Merck Sharp & Dohme LLC


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • P03435
    First Posted:
    Apr 7, 2008
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2022