The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Atherosclerosis

In brief

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.

Key facts

Study ID

NCT00799903

Run by

GlaxoSmithKline

People needed

15828

Starts

2008-12-01

Expected to finish

2013-10-17

Last updated by the study team

2017-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Huntsville, Alabama, United States
• GSK Investigational Site — Anchorage, Alaska, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Concord, California, United States
• GSK Investigational Site — Lomita, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Madera, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — Poway, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Ramon, California, United States
• GSK Investigational Site — Santa Ana, California, United States
• GSK Investigational Site — Spring Valley, California, United States
• GSK Investigational Site — Thousand Oaks, California, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Golden, Colorado, United States
• GSK Investigational Site — Thornton, Colorado, United States
• GSK Investigational Site — Bridgeport, Connecticut, United States
• GSK Investigational Site — Bridgeport, Connecticut, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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