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

NCT ID: NCT00653445

Last Updated: 2009-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2005-06-30

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.

Conditions

Hypercholesterolemia; Coronary Heart Disease; Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Rosuvastatin 40mg/Ezetimibe 10mg combination therapy

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

40mg

Ezetimibe

Intervention Type: DRUG

10mg

2

Rosuvastatin 40 mg

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

40mg

Interventions

Rosuvastatin

40mg

Intervention Type: DRUG

Ezetimibe

10mg

Intervention Type: DRUG

Other Intervention Names

Crestor; Zetia

Eligibility Criteria

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)..

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

AstraZeneca

Principal Investigators

Christine Ballantyne, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for prevention of cardiovascular disease, Texas, USA

Other Identifiers

D3569C00006

Identifier Type: -

Identifier Source: org_study_id