IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

AstraZeneca442 enrolled

Overview

The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa \& Type IIb Dyslipidaemia

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

442

Conditions

Fredrickson Type IIa & Type IIb Dyslipidaemia

Interventions

RosuvastatinDRUG

SimvastatinDRUG

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 creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period. * Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Outcomes

Primary Outcomes

Development of Proteinuria

Time frame: 2 weekly

Secondary Outcomes

Renal effects of rosuvastatin and simvastatin

Time frame: 2 weekly

Low density lipoproteins cholesterol levels

Time frame: 2 weekly

Safety: adverse events & abnormal laboratory markers

Time frame: 2 weekly

Data from ClinicalTrials.gov

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