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NCT00092599 Clinical Trial

Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)

Hypercholesterolemia Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00092599
Other study ID # 0653-801
Secondary ID 2004_039
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2003
Est. completion date July 2004

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate patients who have coronary heart disease to determine if an investigational drug will further lower cholesterol when taken in combination with an approved cholesterol lowering medication.

Description:

The duration of treatment is 10 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 410
Est. completion date July 2004
Est. primary completion date June 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with elevated cholesterol and coronary heart disease Exclusion Criteria: - Patients who do not meet specific cholesterol levels as required by the study

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0653, ezetimibe

• Comparator: ezetimibe, placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Brohet C, Banai S, Alings AM, Massaad R, Davies MJ, Allen C. LDL-C goal attainment with the addition of ezetimibe to ongoing simvastatin treatment in coronary heart disease patients with hypercholesterolemia. Curr Med Res Opin. 2005 Apr;21(4):571-8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment
Secondary Safety and tolerability.
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