An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)

Phase 3

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00092664
• Lead Sponsor: Organon and Co

Brief Summary

The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Study First Submitted: 2004-09-23
• Study First Submitted QC: 2004-09-27
• Study First Posted: 2004-09-28
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1104

Inclusion Criteria

• High cholesterol

Exclusion Criteria

• Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Plasma LDL-C.

Secondary Outcome Measures

Name	Time	Method
Plasma TG and HDL-C; proportion of patients achieving LDL-C targets; tolerability.