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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00657527
First received: April 8, 2008
Last updated: March 13, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Myocardial Ischaemia
Coronary Artery Disease
Drug: Rosuvastatin
Behavioral: Cholesterol lowering diet
Phase 3

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
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring. [ Time Frame: 8 weekly ]

Secondary Outcome 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 ]

Estimated Enrollment: 280
Study Start Date: December 2001
Study Completion Date: December 2002
Arms Assigned Interventions
Experimental: 1
Rosuvastatin
Drug: Rosuvastatin
Other Name: Crestor
No Intervention: 2
Diet
Behavioral: Cholesterol lowering diet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657527

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Michael Cressman, DO AstraZeneca
Study Chair: Russell Esterline AstraZeneca
  More Information

No publications provided

Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00657527     History of Changes
Other Study ID Numbers: 4522IL/0043, D3560C00043
Study First Received: April 8, 2008
Last Updated: March 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Crestor
Rosuvastatin
Cholesterol
Coronary artery disease
Myocardial ischaemia.

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Ischemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Vascular Diseases
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014