NCT00651144

Assessment of Potential Interaction Between Ezetimibe and Rosuvastatin in Healthy Subjects With High Cholesterol (P03317)

SCH 058235: Assessment of a Multiple-Dose Drug Interaction Between Ezetimibe and Rosuvastatin in Healthy Hypercholesterolemic Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to obtain data of the coadministration of ezetimibe and rosuvastatin to support the concomitant use of these two drugs in patients requiring additional cholesterol-lowering management. Treatment is administered for 14 days.

Conditions

• Hypercholesterolemia
• Atherosclerosis

Interventions

Type	Name	Description
DRUG	Ezetimibe + Rosuvastatin	oral tablets; rosuvastatin 10 mg + ezetimibe 10 mg, once daily for 14 days
DRUG	Rosuvastatin	oral tablets; rosuvastatin 10 mg + ezetimibe placebo once daily for 14 days
DRUG	Placebo	oral tablets; two ezetimibe placebo once daily for 14 days
DRUG	Ezetimibe	oral tablets; ezetimibe 10 mg + ezetimibe placebo once daily for 14 days

Timeline

• Start date: 2003-03-01
• Primary completion: 2003-05-01
• Completion: 2003-05-01
• First posted: 2008-04-02
• Last updated: 2022-02-17