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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Coronary Heart Disease; Hypercholesterolemia; Atherosclerosis

Treatments: Drug: Ezetimibe; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00653445

D3569C00006

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)..

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1

Experimental group

Description:

Rosuvastatin 40mg/Ezetimibe 10mg combination therapy

Treatment:

Drug: Rosuvastatin

Drug: Ezetimibe

2

Experimental group

Description:

Rosuvastatin 40 mg

Treatment:

Drug: Rosuvastatin