Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg

Phase 3

Completed

• Conditions: Hypercholesterolemia; Coronary Heart Disease; Atherosclerosis
• Interventions: Drug: Rosuvastatin; Drug: Ezetimibe

• Registration Number: NCT00653445
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to compare 6 weeks of treatment with rosuvastatin alone compared with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density lipoprotein level goals.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study Completion: 2005-06
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-07
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-25
• Last Update Posted: 2009-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
• Fasting LDL-C concentrations at Visit 1 as defined in the protocol.
• Discontinuation of all lipid lowering therapy at Visit 1.

Exclusion Criteria

• History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
• Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
• Severe congestive cardiac failure (as defined by the protocol - Appendix I).
• Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1)..

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ezetimibe	Rosuvastatin 40mg/Ezetimibe 10mg combination therapy
2	Rosuvastatin	Rosuvastatin 40 mg
1	Rosuvastatin	Rosuvastatin 40mg/Ezetimibe 10mg combination therapy

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting low-density lipoprotein cholesterol (LDL-C) levels at baseline and Week 6

Secondary Outcome Measures

Name	Time	Method
To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting blood lipid levels levels at baseline and Week 6
Safety: by measuring adverse events & abnormal laboratory markers to compare safety & tolerability of rosuvastatin alone with rosuvastatin combined with ezetimibe