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NCT01743001 · ClinicalTrials.gov registry record · Phase 3

Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome

A Phase 3 study, sponsored by Actelion.

Completed
Registry status
Phase 3
Development phase
226
Enrollment target

NCT01743001: Completed Phase 3 study, sponsored by Actelion.

NCT01743001 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 226 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01743001, a Phase 3 study, has completed, sponsored by Actelion.

COMPLETED
Registry status
Phase 3
Development phase
226 participants
Enrollment target

Study Summary

Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.

Primary Outcome

The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.

Interventions

  • DRUG Placebo
  • DRUG Macitentan 10 mg

Trial Details

FieldValue
Enrollment Target 226 participants
Start Date 2013-05-21
Est. Completion 2016-12-01
Phase Phase 3
Actelion

63 total trials

What the finished NCT01743001 record still lists

NCT01743001 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01743001 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01743001 about?

NCT01743001 is a clinical study titled "Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome". Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.

What is the current status of trial NCT01743001?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2013-05-21. Estimated completion is 2016-12-01.

What interventions are being tested in trial NCT01743001?

The interventions under investigation include: Placebo (DRUG), Macitentan 10 mg (DRUG).

Who is sponsoring clinical trial NCT01743001?

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

How this trial's enrollment target compares

Where NCT01743001's enrollment target sits among peer trials

226 1310th of 2000 higher than 690 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 NCT01743001, the US trial registry maintained by the National Library of Medicine. NCT01743001 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.