To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)

Phase 3

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00271817
• Lead Sponsor: Organon and Co

Brief Summary

To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-01-03
• Study First Submitted QC: 2006-01-03
• Study First Posted: 2006-01-04
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2009-02-13
• Results First Submitted QC: 2009-06-15
• Results First Posted: 2009-08-03
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1220

Inclusion Criteria

• Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL
• Patient willing to be on a low-cholesterol diet

Exclusion Criteria

• Pregnant or lactating women or intending to become pregnant
• Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
• Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin
• Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)	Baseline and 24 weeks	Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)	Baseline and 64 weeks	Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline
Percent Change From Baseline in Triglycerides (TG)	Baseline and 64 weeks	Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)	Baseline and 24 weeks	Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)	Baseline and 64 weeks	Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline