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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 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 187 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03904693
The ClinicalTrials.gov registry entry for NCT03904693 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Macitentan 10 mg is the first listed.
NCT03904693 reports 0 study locations.
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.
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