OLE Study to Evaluate Safety / Efficacy of ZD4522 - Tabular View

Tracking Information

First Received Date ^ICMJE

April 2, 2008

Last Updated Date

March 13, 2009

Start Date ^ICMJE

August 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Safety, as determined by adverse events, laboratory data, physical examination and ECG. [ Time Frame: 12 weekly ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00654303 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Success in achieving goals for Cholesterol levels [ Time Frame: 12 weekly ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

OLE Study to Evaluate Safety / Efficacy of ZD4522

Official Title ^ICMJE

ZD4522 Long Term Extension Trial

Brief Summary

The purpose of this study is to assess the long term safety of Crestor.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Non-Randomized
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Hypercholesterolaemia

Intervention ^ICMJE

Drug: Rosuvastatin

Other Name: Crestor

Study Arms / Comparison Groups

1: Experimental

Rosuvastatin

Intervention: Drug: Rosuvastatin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

3500

Completion Date

February 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Completion of previous Crestor study as listed in the protocol.

Exclusion Criteria:

Pregnant or breast feeding women, or not using appropriate contraception.
Abnormal lab values as listed in the protocol.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00654303

Responsible Party

Elisabeth Björk, AstraZeneca

Study ID Numbers ^ICMJE

4522IL/0034, D3560C00034

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Elinor Miller, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP