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)

ClinicalTrials.gov ID: NCT03904693

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.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Oct 17, 2026, 2:59 AM EDT

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
Lead sponsor: Actelion; Industry
Enrollment: 187 participants

Conditions and interventions

Conditions

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

Interventions

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 29, 2019 (Actual)
Primary completion: Aug 23, 2022 (Actual)
Completion: Sep 27, 2024 (Actual)
Last update posted: Dec 19, 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 19, 2025 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03904693 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →