Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS)

AstraZeneca2,340 enrolled

Overview

The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in South Asian subjects with hypercholesterolemia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,340

Conditions

Hypercholesterolemia Dyslipidaemia

Interventions

RosuvastatinDRUG

AtorvastatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Fasting low density lipoprotein \& triglyceride levels as defined by the protocol. * Self described South Asian race * Subjects with coronary heart disease or at high risk of coronary heart disease. Exclusion Criteria: * The use of lipid lowering drugs or dietary supplements after Visit 1. * Active arterial disease eg Unstable angina, or recent arterial surgery * Blood lipid levels above the limits defined in the protocol. * Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Outcomes

Primary Outcomes

Low density lipoproteins cholesterol levels

Time frame: 6 weeks

Secondary Outcomes

Safety: adverse events & abnormal laboratory markers

Time frame: 6 weeks

Data from ClinicalTrials.gov

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