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

Phase 3

Completed

• Conditions: Coronary Disease; Hypercholesterolemia

• Registration Number: NCT00092599
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

The duration of treatment is 10 weeks.

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2004-06
• Study Completion: 2004-07
• Study First Submitted: 2004-09-23
• Study First Submitted QC: 2004-09-24
• Study First Posted: 2004-09-27
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability.