Completed

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.

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What is being tested

Rosuvastatin

+ Cholesterol lowering diet

DrugBehavioral
Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: December 2001
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2001

Actual date on which the first participant was enrolled.

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.

Official TitleAn 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.
NCT00657527
Principal SponsorAstraZeneca
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

280 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial Ischemia

Criteria

3 inclusion criteria required to participate
Evidence of Coronary arterial disease
Suffering ischaemic episodes/exercise induced ischaemia
Not taking any cholesterol lowering medication
3 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Rosuvastatin

Group II

No Intervention
Diet

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers