NCT00653523

Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)

Open-label, Long-term Study of Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia Who Have Not Reached LDL-cholesterol Target With HMG-CoA Reductase Inhibitors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Ezetimibe	Ezetimibe 10 mg once daily
DRUG	Simvastatin	Simvastatin 20 mg daily

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-04-07
• Last updated: 2024-05-21
• Results posted: 2010-06-30