- CSR Summary Not Yet Available
- NCT01106014
- Primary Citation
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Trial Information
Generic NameSelexipagProduct NameUPTRAVI®Therapeutic AreaHeart and Blood DiseasesEnrollment1156% Female79.8%% White65%
Product ClassProstacyclin receptor agonistSponsor Protocol NumberAC-065A302Data PartnerJohnson & JohnsonCondition StudiedPulmonary Arterial HypertensionMean/Median Age (Years)48.1
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2024-0580 : Developing approaches to accelerate clinical trials using real world data (RWD) from electronic health records (EHR)
- 2024-0400 : Influence of Selexipag on Kidney Function in People with Pulmonary Arterial Hypertension: A Secondary Analysis of the GRIPHON Trial
- 2023-5534 : Quality tolerance limit and duplicated patient investigation in clinical trials
- 2023-5195 : Predictive modeling of adverse events and symptoms patterns in large scale clinical trials
- 2022-5067 : Predictive Value of QT Interval Dispersion in Patients with Pulmonary Arterial Hypertension (PAH)
- 2020-4415 : Development and assessment of Virtual Cohorts derived from historical Pulmonary Arterial Hypertension clinical trials.
- 2019-4075 : Derivation and Validation of Predictive Models in an aggregated Pulmonary Arterial Hypertension cohort