Evaluation of Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease

March 13, 2009 updated by: AstraZeneca

An 8-Week Randomized Double Blind Placebo Controlled Multicenter Trial to Evaluate the Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease.

The purpose of this study is to determine whether treatment with 40mg of Rosuvastatin for 8 weeks will reduce the number of episodes of myocardial ischaemia suffered in subjects with coronary artery disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Evidence of Coronary arterial disease
  • Suffering ischaemic episodes/exercise induced ischaemia
  • Not taking any cholesterol lowering medication

Exclusion Criteria:

  • Unstable angina or heart attack less than one month before trial entry
  • Coronary arterial surgery as defined by protocol
  • Uncontrolled hypertension, diabetes, hypothyroidism or laboratory values as defined by the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Rosuvastatin
Drug: Rosuvastatin
Other Names:
  • Crestor
No Intervention: 2
Diet
Behavioral: Cholesterol lowering diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring.
Time Frame: 8 weekly
8 weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in duration of ischemic episodes
Time Frame: 8 weekly
8 weekly
Safety
Time Frame: 8 weekly
8 weekly
Several laboratory parameters as detailed in the protocol
Time Frame: 8 weekly
8 weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Michael Cressman, DO, AstraZeneca
  • Study Chair: Russell Esterline, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 8, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Estimate)

March 16, 2009

Last Update Submitted That Met QC Criteria

March 13, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4522IL/0043
  • D3560C00043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe