NCT00271817

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

Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,220 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Comparator: ezetimibe/simvastatin + niacin (ER)	ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be \~24 weeks
DRUG	Comparator: Placebo to ezetimibe/simvastatin	ezetimibe/simvastatin (Pbo) tablet. Treatment time will be \~24 weeks.
DRUG	Comparator: niacin (ER) tablet	niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be \~24 weeks
DRUG	Comparator: ezetimibe (+) simvastatin	ezetimibe/simvastatin 10/20mg tablet. Treatment time will be \~24 weeks.
DRUG	Comparator: Placebo to Niacin (ER)	Niacin (ER) (Pbo) tablet. Treatment time will be \~24 weeks.
DRUG	Comparator: ezetimibe/simvastatin and niacin (ER)	ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be \~40 additional weeks for a total of 64 weeks
DRUG	Comparator: ezetimibe and simvastatin	ezetimibe/simvastatin 10/20mg tablet. Treatment time will be \~40 additional weeks for a total of 64 weeks
DRUG	Comparator: Placebo to niacin (ER)	Niacin (ER) (Pbo) tablet. Treatment time will be \~40 additional weeks for a total of 64 weeks

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2006-01-04
• Last updated: 2024-05-16
• Results posted: 2009-08-03