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)
Public ClinicalTrials.gov record NCT03904693. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03904693
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 187 participants
Conditions and interventions
Interventions
- FDC macitentan/tadalafil Drug
- Macitentan 10 mg Drug
- Tadalafil 40 mg Drug
- Placebo FDC Drug
- Placebo macitentan Drug
- Placebo tadalafil Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 28, 2019
- Primary completion
- Aug 22, 2022
- Completion
- Sep 26, 2024
- Last update posted
- Dec 18, 2025
2019 – 2024
United States locations
- U.S. sites
- 26
- U.S. states
- 18
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Providence Medical Foundation | Fullerton | California | 92835 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | — |
| WellStar Health System | Marietta | Georgia | 30060 | — |
| OSF HealthCare Cardiovascular Institute | Peoria | Illinois | 61614 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Norton Healthcare | Louisville | Kentucky | 40202-1332 | — |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | — |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | — |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | — |
| VA Sierra Nevada Health Care System | Reno | Nevada | 89509 | — |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Pitt County Memorial Hospital d/b/a Vidant Medical Center | Greenville | North Carolina | 27835 | — |
| Sanford Health | Fargo | North Dakota | 58122 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| St. Elizabeth Hospital Mercy Bon Secors | Youngstown | Ohio | 44503 | — |
| Legacy Hospital | Portland | Oregon | 97210 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Sanford Health | Sioux Falls | South Dakota | 57105 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Baylor Scott White - Plano | Plano | Texas | 75093 | — |
| WVU Health Sciences Center | Morgantown | West Virginia | 26506 | — |
| University of Wisconsin At Madison | Madison | Wisconsin | 53792 | — |
| Medical College of Wisconsin Froedtert Hospital | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 122 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03904693, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 18, 2025 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03904693 live on ClinicalTrials.gov.