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NCT01847014 · ClinicalTrials.gov registry record · Phase 3

Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument

A Phase 3 study, sponsored by Actelion.

Terminated
Registry status
Phase 3
Development phase
4
Enrollment target

NCT01847014: Clinical Trial Phase 3 study, sponsored by Actelion.

NCT01847014 is a Phase 3 study that was terminated before completion, run by Actelion. The registered enrollment target is 4 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01847014, a Phase 3 study, was terminated before completion, sponsored by Actelion.

TERMINATED
Registry status
Phase 3
Development phase
4 participants
Enrollment target

Study Summary

SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study.

Primary Outcome

Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit.

Interventions

  • DRUG Macitentan

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2013-09-01
Est. Completion 2017-11-30
Phase Phase 3
Actelion

63 total trials

Why NCT01847014 stopped before completion

NCT01847014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Macitentan is the first listed.

NCT01847014 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01847014 about?

NCT01847014 is a clinical study titled "Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument". SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects w...

What is the current status of trial NCT01847014?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 4 participants. The study started on 2013-09-01. Estimated completion is 2017-11-30.

What interventions are being tested in trial NCT01847014?

The interventions under investigation include: Macitentan (DRUG).

Who is sponsoring clinical trial NCT01847014?

This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01847014's enrollment target sits among peer trials

4 1998th of 2000 higher than 2 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01847014, the US trial registry maintained by the National Library of Medicine. NCT01847014 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.