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

No

Study drug

-

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

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria