We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

SB-480848 in Major Adverse Cardiovascular Events - Integrated Summary of Efficacy and Safety From the STABILITY Trial (LPL100601) and the SOLID-TIMI-52 Trial (SB-480848/033)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01636271
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The overall objective of this integrated analysis is to evaluate the clinical safety and efficacy of long-term treatment with darapladib enteric coated tablets, 160mg, as compared to placebo when added to standard of care in subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (CHD) and post Acute Coronary Syndrome (ACS)). With respect to efficacy, the key purpose of this integrated analysis is to evaluate the effects of darapladib on the following endpoints: urgent coronary revascularization for myoacrdial ischemia, fatal/non-fatal stroke, time to subsequent Major Adverse Cardiovascular Event (MACE), and heart failure requiring hospitalization. The first occurrent of MACE, Major and total coronary events as well as the individual components of MACE will also be evaluated descriptively.

Condition or disease Intervention/treatment
Coronary Heart Disease Drug: darapladib Drug: placebo

Detailed Description:

The objective of the integrated safety analysis is to characterize the safety profile of darapladib in subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (CHD) and post Acute Coronary Syndrome (ACS)).

The purpose of the integrated efficacy analysis is to test the effects of darapladib on select endpoints which are not part of the testing hierarchies associated with the individual studies, namely: urgent coronary revascularization for myocardial ischemia, stroke, subsequent MACE, and heart failure requiring hospitalization, For all other endpoints, the intent of the integrated analysis is to provide increased precision of the estimated effects of darapladib.


Study Design

Study Type : Observational
Actual Enrollment : 28855 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SB-480848 in Major Adverse Cardiovascular Events - Integrated Phase III Summary of Efficacy and Safety
Study Start Date : October 2011
Primary Completion Date : April 2014
Study Completion Date : April 2014
Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1: subjects from LPL100601
randomized subjects in study LPL100601
Drug: darapladib
darapladib enteric coated tablets 160 mg
Drug: placebo
placebo
Group 2: subjects from SB480848/033
randomized subjects in study SB480848/033
Drug: darapladib
darapladib enteric coated tablets 160 mg
Drug: placebo
placebo


Outcome Measures

Primary Outcome Measures :
  1. The time to first occurrence of urgent coronary revascularization for myocardial ischemia [ Time Frame: visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study. ]
    time to the first occurrence of any urgent coronary revascularization for myocardial ischemia

  2. The time to first occurrence of stroke (fatal/non-fatal) [ Time Frame: visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study. ]
    time to the first occurrence of stroke (fatal or non-fatal)

  3. The time to subsequent Major Adverse Cardiovascular Events (MACE) [ Time Frame: visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study. ]
    time to subsequent composite of MACE (CV death, non-fatal MI or non-fatal stroke)

  4. The time to first occurrence of heart failure requiring hospitalization [ Time Frame: visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study. ]
    time to the first occurrence of heart failure requiring hospitalization


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (CHD) or post Acute Coronary Syndrome (ACS)) randomized into the STABILITY trial (LPL100601) or the SOLID-TIMI 52 trial (SB-480848/033).
Criteria

Inclusion Criteria:

  • This is an integrated analysis therefore inclusion criteria are not applicable.

Exclusion Criteria:

  • This is an integrated analysis therefore exclusion criteria are not applicable.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636271


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01636271     History of Changes
Other Study ID Numbers: 116740
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014

Keywords provided by GlaxoSmithKline:
CV Risk
Cardiovascular Disease
Atherosclerosis
Acute coronary syndrome

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Darapladib
Phospholipase A2 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action