Last updated: 11/03/2018 19:31:25

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)

GSK study ID
116740
Clinicaltrials.gov ID
NCT01636271
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: SB-480848 in Major Adverse Cardiovascular Events - Integrated Phase III Summary of Efficacy and Safety
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The time to first occurrence of urgent coronary revascularization for myocardial ischemia

Timeframe: 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.

The time to first occurrence of stroke (fatal/non-fatal)

Timeframe: 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.

The time to subsequent Major Adverse Cardiovascular Events (MACE)

Timeframe: 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.

The time to first occurrence of heart failure requiring hospitalization

Timeframe: 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.

Secondary outcomes:
Not applicable
Interventions:
  • Drug: darapladib
  • Drug: placebo
    • Enrollment:
    28855
    Primary completion date:
    2014-30-04
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Coronary heart disease
    Product
    darapladib
    Collaborators
    Not applicable
    Study date(s)
    October 2011 to April 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • This is an integrated analysis therefore inclusion criteria are not applicable.
    • This is an integrated analysis therefore exclusion criteria are not applicable.
    Inclusion and exclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    2014-30-04
    Actual study completion date
    2014-30-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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