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COMPLETED Phase 3

The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension

NCT02558231 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Tadalafil
  • DRUG Selexipag
  • DRUG Macitentan

Study Locations (20)

California

  • UCSD Health Sciences — La Jolla
  • UCLA Medical Center — Los Angeles

Florida

  • Mayo Clinic Jacksonville — Jacksonville
  • Cleveland Clinic Florida — Weston

Massachusetts

  • Tufts Medical Center — Boston
  • Boston University Medical Center — Boston

Pennsylvania

  • Allegheny General Hospital of Research — Pittsburgh
  • UPMC Presbyterian — Pittsburgh

Texas

  • University of Texas Southwestern Medical Center — Dallas
  • Houston Methodist Hospital — Houston

Arizona

  • Arizona Pulmonary Specialists, LTD — Phoenix

Georgia

  • Piedmont Pulmonary and Critical Care Research — Atlanta

Illinois

  • Northwestern University — Chicago

Trial Details

FieldValue
Enrollment Target 247 participants
Start Date 2016-05-01
Est. Completion 2020-04-20
Phase Phase 3

Sponsor

Actelion

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02558231

The ClinicalTrials.gov registry entry for NCT02558231 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 3 interventions — of which Tadalafil is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02558231 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02558231 about?

NCT02558231 is a clinical study titled "The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension". 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 arteria...

What is the current status of trial NCT02558231?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 247 participants. The study started on 2016-05-01. Estimated completion is 2020-04-20.

What conditions does trial NCT02558231 study?

This clinical trial studies the following conditions: Pulmonary Arterial Hypertension. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02558231?

The interventions under investigation include: Tadalafil (DRUG), Selexipag (DRUG), Macitentan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02558231?

This trial is sponsored by Actelion, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02558231 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial