48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety

AstraZeneca1,500 enrolled

Overview

The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,500

Conditions

Dyslipidaemia

Interventions

RosuvastatinDRUG

Maintenance of specific dietBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Fasting low density lipoprotein level as defined by the protocol. * Fasting triglyceride level as defined by the protocol. 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

Reduction in low density lipoprotein cholesterol levels

Time frame: 12 weeks

Secondary Outcomes

Reduction in low density lipoprotein cholesterol levels

Time frame: 24 & 48 weeks

Safety: adverse events & abnormal laboratory markers

Time frame: 4 weekly until week 12 then 12 weekly thereafter.

Maintenance of lowered low density lipoprotein cholesterol level

Time frame: Between week 12-48

Data from ClinicalTrials.gov

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