Last updated: 11/03/2018 21:53:47

Exploratory Investigation of Associations between Genome-wide Genetic Variants and Response to Darapladib in the STABILITY (LPL100601) and SOLID-TIMI 52 (SB-480848/033) Trials (PGX7615)

GSK study ID
201769
See study documents
Clinicaltrials.gov ID
Not applicable
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: Exploratory Investigation of Associations between Genome-wide Genetic Variants and Response to Darapladib in the STABILITY (LPL100601) and SOLID-TIMI 52 (SB-480848/033) Trials (PGX7615)
Trial description: This exploratory pharmacogenetic (PGx) analysis will test the hypothesis that genetic variants may be associated with differential safety/tolerability and efficacy as well as pharmacokinetics (PK)/ pharmacodynamics (PD) in response to darapladib treatment, or may be associated with the drug target baseline LpPLA2 enzyme activity, using data from the STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY (STABILITY) and the Stabilization of pLaques usIng Darapladib—Thrombolysis in Myocardial Infarction (SOLID-TIMI 52) trials.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Determine if genetic variants are associated with renal failure serious adverse events in response to darapladib treatment.

Timeframe: Observed post-randomization during the LPL100601 or SB480848-033 clinical study

Determine if genetic variants are associated with tolerability endpoints, including diarrhea and bathroom odor event, in response to darapladib treatment.

Timeframe: Observed post-randomization during the LPL100601 or SB480848-033 clinical study

Determine if genetic variants are associated with variation in pharmacokinetics (area under curve [AUC] and maximum concentration [Cmax]) in response to darapladib treatment.

Timeframe: Observed post-randomization during the LPL100601 or SB480848-033 clinical study

Secondary outcomes:

Determine if genetic variants are associated with tolerability endpoints, including moderate/severe diarrhea and non-bathroom odor event, in response to darapladib treatment.

Timeframe: Observed post-randomization during the LPL100601 or SB480848-033 clinical study

Determine if genetic variants are associated with differential efficacy, including myocardial contrast echocardiography and myocardial infarction, in response to darapladib treatment.

Timeframe: Observed post-randomization during the LPL100601 or SB480848-033 clinical study

Determine if genetic variants are associated with baseline and change from baseline estimated glomerular filtration rate.

Timeframe: Observed post-randomization during the LPL100601 or SB480848-033 clinical study

Determine if genetic variants are associated with stroke (adjudicated fatal stroke or any stroke) in response to darapladib treatment.

Timeframe: Observed post-randomization during the LPL100601 or SB480848-033 clinical study

Determine if genetic variants are associated with baseline and change from baseline Lp-PLA2 enzyme activity.

Timeframe: Observed post-randomization during the LPL100601 or SB480848-033 clinical study

Interventions:
  • Drug: Darapladib
  • Drug: Standard Therapy
  • Drug: Placebo
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    acute coronary syndrome
    Product
    darapladib
    Collaborators
    Not applicable
    Study date(s)
    November 2014 to June 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Subjects who provided written informed consent for genetic analysis and a deoxyribonucleic acid (DNA) sample, were successfully genotyped and have the relevant clinical outcome data available will be included in the study.
    • Subjects who did not provide written informed consent for genetic analysis, a DNA sample, who failed genotyping or who lack the relevant clinical outcome data will be excluded from study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects who provided written informed consent for genetic analysis and a deoxyribonucleic acid (DNA) sample, were successfully genotyped and have the relevant clinical outcome data available will be included in the study.
    Exclusion criteria:
    • Subjects who did not provide written informed consent for genetic analysis, a DNA sample, who failed genotyping or who lack the relevant clinical outcome data will be excluded from study.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2015-24-06

    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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