NCT00871351

Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

Ezetimibe Phase IV Clinical Study in Patients With Hypercholesterolemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Conditions

• Primary Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Ezetimibe	1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
DRUG	Atorvastatin	1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
DRUG	Atorvastatin	2 tablets of 10 mg daily for 12 weeks (Weeks 5-16)
DRUG	Rosuvastatin	1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-03-30
• Last updated: 2024-05-23
• Results posted: 2011-08-23