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NCT00657527 Clinical Trial

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

Coronary Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00657527
Other study ID # 4522IL/0043
Secondary ID D3560C00043
Status Completed
Phase Phase 3
First received April 8, 2008
Last updated March 13, 2009
Start date December 2001
Est. completion date December 2002

Study information
Verified date March 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 280
Est. completion date December 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Rosuvastatin

Behavioral:
• Cholesterol lowering diet

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Outcome
Type Measure Description Time frame Safety issue
Primary Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring. 8 weekly
Secondary Change in duration of ischemic episodes 8 weekly
Secondary Safety 8 weekly
Secondary Several laboratory parameters as detailed in the protocol 8 weekly
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