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

ClinicalTrials.gov processed this record on April 15, 2014