IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2004-04-30

Brief Summary

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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

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Detailed Description

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Conditions

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Fredrickson Type IIa & Type IIb Dyslipidaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Rosuvastatin

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

2

Simvastatin

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

Interventions

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Rosuvastatin

Intervention Type DRUG

Simvastatin

Intervention Type DRUG

Other Intervention Names

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Crestor Zocor

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No