Compare the efficacy of rosuvastatin to atorvastatin in high risk patients with hypercholesterolemia

Study identifier:D356FC00007

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomised, double-blind trial to compare the efficacy of rosuvastatin 5 and 10 mg to atorvastatin 10 mg in the treatment of high risk patients with hypercholesterolemia followed by an open label treatment period with rosuvastatin up-titrated to the maximum dose of 20 mg for those patients who do not achieve goal

Medical condition

Hypercholesterolemia

Phase

Phase 3

Healthy volunteers

Study drug

Rosuvastatin, Atorvastatin

Sex

All

Actual Enrollment

934

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 May 2008

Primary Completion Date: 01 Jul 2009

Study Completion Date: 01 Jul 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2012 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Changsha, Hunan, China

Location

Research Site

Beijing, China

Location

Research Site

Shanghai, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Shenyang, Liaoning, China

Location

Research Site

Tianjin, China

Arms	Assigned Interventions
Experimental: 1 Rosuvastatin 5mg qd	Drug: Rosuvastatin Capsule/Tablet, oral, qd, 6 or 12 weeks Other Name: Crestor
Experimental: 2 Rosuvastatin 10mg qd	Drug: Rosuvastatin Capsule/Tablet, oral, qd, 6 or 12 weeks Other Name: Crestor
Active Comparator: 3 Atorvastatin 10mg qd	Drug: Atorvastatin Capsule/Tablet, 10mg, oral, qd, 6 weeks Other Name: Lipitor

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=328&filename=CSR-D356FC00007.pdf
Download
CSR-D356FC00007.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Marco Avila

86-21-52564555

marco.avila@astrazeneca.com

Investigators

Principal Investigator

Marie Eckerd

AZ Pharmaceuticals - US

Compare the efficacy of rosuvastatin to atorvastatin in high risk patients with hypercholesterolemia

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=328&filename=CSR-D356FC00007.pdf

CSR-D356FC00007.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator