The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial

• Status: Completed
• Trial end date: 2013-10-17
• Target enrollment: 0
• Participant gender: All

Summary

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Darapladib

Criteria

Inclusion Criteria:

• Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.

• Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.

• Chronic coronary heart disease

• At least one of the following:

• At least 60 years old

• Diabetes requiring treatment with medication

• Low HDL cholesterol ("good cholesterol")

• Currently smoke cigarettes or stopped smoking within the past 3 months

• Diagnosed mild or moderate reduction in kidney function

• Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral arterial disease.

Exclusion Criteria:

• Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.

• Liver disease

• Severe reduction in kidney function OR removal of a kidney OR kidney transplant

• Severe heart failure

• Blood pressure higher than normal despite lifestyle changes and treatment with medications

• Any life-threatening disease expected to result in death within the next 2 years (other than heart disease)

• Severe asthma that is poorly controlled with medication

• Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)

• Previous severe allergic response to food, drink, insect stings, etc.

• Drug or alcohol abuse within the past 6 months OR mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.

• Certain medications that may interfere with the study medication (these will be identified by the study doctor)

• Participation in a study of an investigational medication within the past 30 days

• Current participation in a study of an investigational device