Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination Therapy

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT03904693

Title field or adapter rule

protocolSection.identificationModule.officialTitle

Ingested At

2026-04-25T22:28:47.268284+00:00

Published At

2023-11-13T00:00:00+00:00

Record Updated At

2025-12-19

Results Posted At

2023-11-13

Timestamp Basis

source retrieval time was not retained by the feed adapter

Date limitation

source retrieval time was not retained by the feed adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)"]

protocolSection.statusModule.lastUpdatePostDateStruct.date

"2025-12-19"

protocolSection.identificationModule.nctId

"NCT03904693"

protocolSection.identificationModule.officialTitle

"Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination Therapy"

protocolSection.statusModule.overallStatus

"COMPLETED"

protocolSection.designModule.phases

["PHASE3"]

protocolSection.statusModule.resultsFirstPostDateStruct.date

"2023-11-13"

Study condition terms

• Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) (protocolSection.conditionsModule.conditions)

Intervention details are not present in the imported fields for this record. No drug-condition relationship is inferred from co-listing.

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