IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00654446

Enrollment

442

Registered

2008-04-08

Start date

2002-09-30

Completion date

2004-04-30

Last updated

2009-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fredrickson Type IIa & Type IIb Dyslipidaemia

Keywords

Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Simvastatin, Zocor, Renal, kidney

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

Interventions

DRUGRosuvastatin

DRUGSimvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Development of Proteinuria	2 weekly

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026