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

Study Overview
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Brief Summary
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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.

Official Title
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A 6wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel Group Study to Compare the Safety & Efficacy of Rosuvastatin 40mg in Comb.With Ezetimibe 10mg in Subjects With Hypercholesterolaemia & CHD or Atherosclerosis or a CHD Risk Equiv. (10 yr Risk Score >20%).

Conditions
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Hypercholesterolemia, Coronary Heart Disease, Atherosclerosis

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Ezetimibe


Participation Criteria
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Eligibility Criteria
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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)..

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rosuvastatin 40mg/Ezetimibe 10mg combination therapy | Drug: Rosuvastatin<br>* 40mg<br>* Other names: Crestor;Drug: Ezetimibe<br>* 10mg<br>* Other names: Zetia;|
| Experimental: 2<br>Rosuvastatin 40 mg | Drug: Rosuvastatin<br>* 40mg<br>* Other names: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low density lipoproteins, Hypercholesterolemia, Coronary Heart Disease, Rosuvastatin, Crestor, Ezetimibe