# Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

> **NCT03904693** · PHASE3 · COMPLETED · sponsor: **Actelion** · enrollment: 187 (actual)

## Conditions studied

- Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)

## Interventions

- **DRUG:** FDC macitentan/tadalafil
- **DRUG:** Macitentan 10 mg
- **DRUG:** Tadalafil 40 mg
- **DRUG:** Placebo FDC
- **DRUG:** Placebo macitentan
- **DRUG:** Placebo tadalafil

## Key facts

- **NCT ID:** NCT03904693
- **Lead sponsor:** Actelion
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-07-29
- **Primary completion:** 2022-08-23
- **Final completion:** 2024-09-27
- **Target enrollment:** 187 (ACTUAL)
- **Last updated:** 2025-12-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03904693

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03904693, "Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT03904693. Licensed CC0.

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