We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00657527
First Posted: April 14, 2008
Last Update Posted: March 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657527


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

Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00657527     History of Changes
Other Study ID Numbers: 4522IL/0043
D3560C00043
First Submitted: April 8, 2008
First Posted: April 14, 2008
Last Update Posted: March 16, 2009
Last Verified: March 2009

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 Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors