The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension
Public ClinicalTrials.gov record NCT02558231. 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
The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.
Study identification
- NCT ID
- NCT02558231
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 247 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- May 1, 2016 (Actual)
- Primary completion
- Aug 29, 2019 (Actual)
- Completion
- Apr 20, 2020 (Actual)
- Last update posted
- Mar 30, 2025
2016 – 2020
United States locations
- U.S. sites
- 20
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Pulmonary Specialists, LTD | Phoenix | Arizona | 85012 | — |
| UCSD Health Sciences | La Jolla | California | 92093 | — |
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Piedmont Pulmonary and Critical Care Research | Atlanta | Georgia | 30309 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| Kentuckiana Pulmonary Associates | Louisville | Kentucky | 40202 | — |
| LSU Health Sciences Center | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21205 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111-1552 | — |
| Boston University Medical Center | Boston | Massachusetts | 02118-2526 | — |
| Washington University School of Medicine | Saint Louis | Michigan | 63110 | — |
| University of New Mexico Hospital | Albuquerque | New Mexico | 87106 | — |
| The Christ Hospital | Cincinnati | Ohio | 45219-2906 | — |
| Allegheny General Hospital of Research | Pittsburgh | Pennsylvania | 15212 | — |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8550 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
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 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02558231, 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 Mar 30, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02558231 live on ClinicalTrials.gov.