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NCT00654303 Clinical Trial

OLE Study to Evaluate Safety / Efficacy of ZD4522

Hypercholesterolaemia Clinical Trial

Official title:
ZD4522 Long Term Extension Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00654303
Other study ID # 4522IL/0034
Secondary ID D3560C00034
Status Completed
Phase Phase 3
First received April 2, 2008
Last updated March 13, 2009
Start date August 1999
Est. completion date February 2005

Study information
Verified date March 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines AgencySpain: Spanish Agency of MedicinesFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyIreland: Ministry of HealthIsrael: Ministry of HealthItaly: Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines AgencyPoland: Ministry of HealthSweden: The National Board of Health and WelfareUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySouth Africa: Medicines Control Council
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 3500
Est. completion date February 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Rosuvastatin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Outcome
Type Measure Description Time frame Safety issue
Primary Safety, as determined by adverse events, laboratory data, physical examination and ECG. 12 weekly
Secondary Success in achieving goals for Cholesterol levels 12 weekly
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