The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00799903

Purpose

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.

Condition	Intervention	Phase
Atherosclerosis Cardiovascular Disease Coronary Heart Disease CV Risk	Drug: Darapladib Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Attack Heart Diseases

Drug Information available for: Darapladib

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Time to the first occurrence of any component of the composite of Major Adverse Cardiovascular Events [MACE: CV death (death due to a cardiovasacular cause), non-fatal myocardial infarction, non-fatal stroke] [ Time Frame: Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The composite measure of major coronary events that include the time to first occurrence of coronary heart disease death, non-fatal myocardial infarction or urgent coronary revascularization for myocardial ischemia [ Time Frame: Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years. ] [ Designated as safety issue: No ]
The composite measure of total coronary events that include the time to first occurrence of coronary heart disease death, non-fatal myocardial infarction, hospitalization for unstable angina , or any coronary revascularization procedure [ Time Frame: Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years. ] [ Designated as safety issue: No ]
The time to individual components of MACE [cardiovascular death, myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal) ] [ Time Frame: Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years. ] [ Designated as safety issue: No ]
The time to the first occurrence of any component of the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years. ] [ Designated as safety issue: No ]
All cause mortality [ Time Frame: Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years. ] [ Designated as safety issue: No ]

Estimated Enrollment:	15500
Study Start Date:	December 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Darapladib: Experimental Single daily oral tablet	Drug: Darapladib Lp-PLA2 inhibitor administered in addition to standard therapy
Placebo: Placebo Comparator Single daily oral tablet	Drug: Placebo Placebo administered in addition to standard therapy

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 return for clinic visits at 1 month, 3 months, and every 6 months until the end of the study. Average time in the study for an individual subject is expected to be about 3 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799903

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 652 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	100601
Study First Received:	November 26, 2008
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00799903 History of Changes
Health Authority:	Argentina: Ministry of Health - A.N.M.A.T; Belgium: Agence Fédérale des Médicaments et des Produits de la Santé; Brazil: Institutional Review Board; Bulgaria: The Bulgarian Drug Agency; Canada: Health Canada; Chile: Institutional Review Board; China: State Food and Drug Administration; Czech Republic: Státní ústav pro kontrolu léčiv, Oddělení klinického hodnocení; Denmark: Lægemiddelstyrelsen; Estonia: State Agency of Medicines; France: Agence Française de Sécurité Sanitaire des Produits de Santé; Germany: Bundesinstitut für Arzneimittel und Medizinprodukte; Greece: National Drug Organisation; Hungary: Országos Gyógyszerészeti Intézet; Italy: Comitato Etico Unico per la Provincia di Parma; Pakistan: Drug Controller R&D Ministry of Health; Peru: Institutional Review Board; Philippines: Bureau of Food and Drugs; Poland: URZ.D REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH,CEBK; Romania: Agentia Nationala a Medicamentului; Slovak Republic: Štátny ústav pre kontrolu liečiv; South Africa: Medicines Control Council; South Korea: Food and Drug Administration; Spain: Agencia Española del Medicamento y Productos Sanitarios; Sweden: Läkemedelsverket; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; Netherlands: De Centrale Commissie Mensgebonden Onderzoek; Norway: Statens Legemiddelverk

Keywords provided by GlaxoSmithKline:

Atherosclerosis
coronary heart disease
cardiovascular disease
heart disease
Lp-PLA2 inhibitor

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Ischemia
Arteriosclerosis
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 10, 2009