STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00654537

Collaborator

(none)

5,625

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin & simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: Rosuvastatin Drug: Atorvastatin Drug: Pravastatin Drug: Simvastatin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5625 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A 6 Week Open Label, Dose Comparison Study to Evaluate the Safety and Efficacy of Rosuvastatin Versus Atorvastatin, Pravastatin, and Simvastatin in Subjects With Hypercholesterolemia.

Study Start Date :

Apr 1, 2001

Actual Study Completion Date :

Oct 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Rosuvastatin	Drug: Rosuvastatin Other Names: Crestor
Active Comparator: 2 Atorvastatin	Drug: Atorvastatin Other Names: Lipitor
Active Comparator: 3 Pravastatin	Drug: Pravastatin Other Names: Lipostat
Active Comparator: 4 Simvastatin	Drug: Simvastatin Other Names: Zocor

Outcome Measures

Primary Outcome Measures

Percentage change in low density lipoprotein cholesterol. [4 & 6 weeks]

Secondary Outcome Measures

Percentage change in other lipid parameters as defined by the protocol [6 weeks]
Safety evaluation [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Discontinuation of all previous lipid lowering therapy.
Fasting LDL-c levels of between 160mg/dl - 250 mg/dl at Visits 2 & 3 for subjects not on lipid lowering therapy at Visit 1.
Other lipid parameters as specified in the protocol.