48-wk Open Label Phase IIIb to evaluate efficacy and safety

Study identifier:4522IL/0091

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 48 week, open label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and safety of the Lipid-Regulating agent Rosuvastatin in the treatment of subjects with Fredrickson Type IIa and Type IIb Dyslipidaemia, including Heterozygous Familial Hypercholesterolaemia.

Medical condition

dyslipidaemia

Phase

Phase 3

Healthy volunteers

Study drug

Rosuvastatin

Sex

All

Actual Enrollment

1500

Study type

Interventional

Age

18 Years - 150 Years

Date

Study Start Date: 01 Feb 2002

Primary Completion Date: -

Study Completion Date: 01 Nov 2004

Study design

Allocation: N/A
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions

Documents available

CSR-4522IL-0091.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

null AstraZeneca Clinical Study Information

1-800-236-9933

[email protected]

Investigators

Principal Investigator

Dr. Evan Stein

Metabolic & Athersclerotic research centre, USA