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NCT03904693 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 3
- Development phase
- 187
- Enrollment target
NCT03904693: Completed Phase 3 study, sponsored by Actelion.
NCT03904693 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 187 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03904693, a Phase 3 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 187 participants
- Enrollment target
Study Summary
Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.
Primary Outcome
Change in PVR expressed as the ratio of geometric means of EDBT to baseline were reported.
Interventions
- DRUG Macitentan 10 mg
- DRUG FDC macitentan/tadalafil
- DRUG Tadalafil 40 mg
- DRUG Placebo FDC
- DRUG Placebo macitentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2019-07-29 |
| Est. Completion | 2024-09-27 |
| Phase | Phase 3 |
What the finished NCT03904693 record still lists
NCT03904693 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 5 interventions - of which Macitentan 10 mg is the first listed.
NCT03904693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03904693 about?
NCT03904693 is a clinical study titled "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)". Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcom...
What is the current status of trial NCT03904693?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 187 participants. The study started on 2019-07-29. Estimated completion is 2024-09-27.
What interventions are being tested in trial NCT03904693?
The interventions under investigation include: Macitentan 10 mg (DRUG), FDC macitentan/tadalafil (DRUG), Tadalafil 40 mg (DRUG), Placebo FDC (DRUG), Placebo macitentan (DRUG).
Who is sponsoring clinical trial NCT03904693?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03904693's enrollment target sits among peer trials
187 1410th of 2000 higher than 589 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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