Lipid Efficacy/Tolerability Study (0524A-020)

Phase 3

Completed

• Conditions: Primary Hypercholesterolaemia; Mixed Hyperlipidaemia

• Registration Number: NCT00269204
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A 28-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9 scheduled clinic visits, and 3 treatment groups. A patient can be randomly assigned to 1 of the 3 treatment groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2005-12-21
• Study First Posted: 2005-12-23
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-24
• Last Update Posted: 2015-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1620

Inclusion Criteria

• Patients 18 to 85 years of age with Primary Hypercholesterolemia or Mixed Hyperlipidemia with LDL-C below 100 mg/dL for high risk patients (patients with Coronary Artery Disease (CHD).
• Have medical conditions considered to be CHD equivalent).
• LDL-C below 130 mg/dL for patients with multiple risk factors.
• LDL-C between 130 and 190 mg/dL for patients with low risk and Triglycerides </= to 350 mg/dL.

Exclusion Criteria

• A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study, patients < 20% compliance, patients with chronic medical conditions, patients with unstable doses of medications.
• Pregnant or lactating women, or women intending to become pregnant are excluded.
• Patient with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin).
• Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, gout (within 1 year).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reductions of LDL-C concentrations at 24 weeks and better tolerability	at 24 weeks

Secondary Outcome Measures

Name	Time	Method
Elevations in HDL-C concentrations at 24 weeks	at 24 weeks