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

AstraZeneca

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Hypercholesterolemia Coronary Heart Disease Atherosclerosis

Interventions

RosuvastatinDRUG

40mg

EzetimibeDRUG

10mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)..

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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