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

Verified by: AstraZeneca, March 2009
First Received: April 8, 2008 | Last Updated: March 13, 2009 | Phase: Phase 3 | Start Date: December 2001
Overall Status: Completed | Estimated Enrollment: 280
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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...

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: Rosuvastatin
  • Behavioral: Cholesterol lowering diet

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Rosuvastatin
  • No Intervention: 2
    • Diet

Outcome Measures for this Clinical Trial

Primary Measures

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

Secondary Measures

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

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Michael Cressman, DO Study Director AstraZeneca  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00657527

Study ID Number: 4522IL/0043

ClinicalTrials.gov Identifier: NCT00657527

Health Authority: United States: Food and Drug Administration

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00657527