Evaluation of Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00657527

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 III

MedlinePlus related topics: Cholesterol Coronary Artery Disease

Drug Information available for: Rosuvastatin Rosuvastatin calcium Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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.

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:	March 2003
Primary Completion Date:	December 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Rosuvastatin	Drug: Rosuvastatin
2: No Intervention 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

Responsible Party:	AstraZeneca ( Elisabeth Björk )
Study ID Numbers:	4522IL/0043, D3560C00043
Study First Received:	April 8, 2008
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00657527
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Crestor
Rosuvastatin
Cholesterol
Coronary artery disease
Myocardial ischaemia.

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Rosuvastatin
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009