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)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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