Status:
COMPLETED
The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial
Lead Sponsor:
GlaxoSmithKline
Conditions:
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to retur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2013
Estimated Enrollment :
15828 Patients enrolled
Trial Details
Trial ID
NCT00799903
Start Date
December 1 2008
End Date
October 17 2013
Last Update
August 10 2017
Active Locations (650)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35235
2
GSK Investigational Site
Birmingham, Alabama, United States, 35294-0007
3
GSK Investigational Site
Huntsville, Alabama, United States, 35801
4
GSK Investigational Site
Anchorage, Alaska, United States, 99508