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CSR Summary Not Yet Available
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NCT00903331
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Primary Citation
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Data Specification Not Available
Trial Information
Generic NameMacitentanProduct NameOPSUMIT®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment178% Female32%% WhiteN/A
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-055B201Data PartnerJohnson & JohnsonCondition StudiedIdiopathic Pulmonary FibrosisMean/Median Age (Years)64.9
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
- 2022-5070 : An individual patient data meta-analysis of clinical endpoints in pulmonary hypertension with interstitial lung disease (ILD-PH)
- 2022-4951 : What are the re-identification risk scores of publicly available anonymised clinical trial datasets?
- 2021-4571 : Risk factors of DU and related outcomes from post-hoc Analyses of the DUAL-1 & DUAL 2 RCTs In the YODA project : the DADDI YODA project
- 2020-4215 : A systematic review and individual patient data meta-analysis of physiological biomarkers in idiopathic pulmonary fibrosis