IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

Condition(s) targeted: Fredrickson Type IIa & Type IIb Dyslipidaemia

Intervention: Rosuvastatin (Drug); Simvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Evan Stein, Principal Investigator, Affiliation: Metabolic & Athersclerotic research centre, Cincinatti, USA
Russell Esterline, Study Director, Affiliation: AstraZeneca

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

Official title: A 6-wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Sub's With Fredrickson Type IIa & Type IIb Dyslipidaemia, Inc. Heterozygous Familial Hypercholesterolaemia

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Development of Proteinuria

Secondary outcome:

Renal effects of rosuvastatin and simvastatin

Low density lipoproteins cholesterol levels

Safety: adverse events & abnormal laboratory markers

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Starting date: September 2002
Ending date: July 2004
Last updated: April 3, 2008