An Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-804)(COMPLETED)

Phase 3

Completed

• Conditions: Hypercholesterolemia; Coronary Disease

• Registration Number: NCT00092638
• Lead Sponsor: Organon and Co

Brief Summary

The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

Detailed Description

The duration of treatment is 10 weeks.

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2004-07
• Study Completion: 2004-08
• 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: 450

Inclusion Criteria

• Patients with elevated cholesterol and coronary heart disease

Exclusion Criteria

• Patients whose cholesterol levels measure within acceptable ranges as specified by the study requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability.