IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

Phase 3

Completed

• Conditions: Fredrickson Type IIa & Type IIb Dyslipidaemia
• Interventions: Drug: Simvastatin; Drug: Rosuvastatin

• Registration Number: NCT00654446
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study Completion: 2004-04
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-08
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Simvastatin	Simvastatin
1	Rosuvastatin	Rosuvastatin

Primary Outcome Measures

Name	Time	Method
Development of Proteinuria	2 weekly

Secondary Outcome Measures

Name	Time	Method
Renal effects of rosuvastatin and simvastatin	2 weekly
Low density lipoproteins cholesterol levels	2 weekly
Safety: adverse events & abnormal laboratory markers	2 weekly