Trial record 1 of 4341 for:
stability
The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial (STABILITY)
This study is ongoing, but not recruiting participants.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00799903
First received: November 26, 2008
Last updated: March 7, 2013
Last verified: March 2013
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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 |
Drug: Darapladib Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | LPL100601, 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:
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: | 15828 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Darapladib
Single daily oral tablet
|
Drug: Darapladib
Lp-PLA2 inhibitor administered in addition to standard therapy
|
|
Placebo Comparator: Placebo
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
Show 634 Study Locations
Show 634 Study LocationsSponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00799903 History of Changes |
| Other Study ID Numbers: | 100601 |
| Study First Received: | November 26, 2008 |
| Last Updated: | March 7, 2013 |
| Health Authority: | Estonia: State Agency of Medicines Chile: Institutional Review Board Brazil: Institutional Review Board Peru: Institutional Review Board Czech Republic: Státní ústav pro kontrolu léčiv, Oddělení klinického hodnocení Spain: Agencia Española del Medicamento y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency Italy: Comitato Etico Unico per la Provincia di Parma Bulgaria: The Bulgarian Drug Agency Argentina: Ministry of Health - A.N.M.A.T Belgium: Agence Fédérale des Médicaments et des Produits de la Santé Romania: Agentia Nationala a Medicamentului Pakistan: Drug Controller R&D Ministry of Health Norway: Statens Legemiddelverk Denmark: Lægemiddelstyrelsen Philippines: Bureau of Food and Drugs Hungary: Országos Gyógyszerészeti Intézet South Africa: Medicines Control Council Slovak Republic: Štátny ústav pre kontrolu liečiv Poland: URZ.D REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH,CEBK Canada: Health Canada Germany: Bundesinstitut für Arzneimittel und Medizinprodukte France: Agence Française de Sécurité Sanitaire des Produits de Santé Netherlands: De Centrale Commissie Mensgebonden Onderzoek China: Food and Drug Administration South Korea: Food and Drug Administration United States: Food and Drug Administration Sweden: Läkemedelsverket Greece: National Drug Organisation |
Keywords provided by GlaxoSmithKline:
|
heart disease Lp-PLA2 inhibitor cardiovascular disease |
coronary heart disease CV risk Atherosclerosis |
Additional relevant MeSH terms:
|
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Plaque, Atherosclerotic |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on June 17, 2013