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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01636271
First received: May 31, 2012
Last updated: September 5, 2013
Last verified: August 2013
  Purpose

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 Intervention
Coronary Heart Disease
Drug: darapladib
Drug: placebo

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SB-480848 in Major Adverse Cardiovascular Events - Integrated Phase III Summary of Efficacy and Safety

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    time to the first occurrence of any urgent coronary revascularization for myocardial ischemia

  • 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. ] [ Designated as safety issue: No ]
    time to the first occurrence of stroke (fatal or non-fatal)

  • 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. ] [ Designated as safety issue: No ]
    time to subsequent composite of MACE (CV death, non-fatal MI or non-fatal stroke)

  • 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. ] [ Designated as safety issue: No ]
    time to the first occurrence of heart failure requiring hospitalization


Enrollment: 28855
Study Start Date: October 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636271

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01636271     History of Changes
Other Study ID Numbers: 116740
Study First Received: May 31, 2012
Last Updated: September 5, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014