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NCT00091715 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II

A Phase 3 study of Pulmonary Hypertension, sponsored by Actelion.

Completed
Registry status
Phase 3
Development phase
185
Enrollment target
20
Study locations

NCT00091715: Completed Phase 3 study of Pulmonary Hypertension, sponsored by Actelion.

NCT00091715 is a Phase 3 study of Pulmonary Hypertension that has completed, run by Actelion. The registered enrollment target is 185 participants, below the 611-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00091715, a Phase 3 study of Pulmonary Hypertension, has completed, sponsored by Actelion.

COMPLETED
Registry status
Phase 3
Development phase
185 participants
Enrollment target
20
Study locations

Study Summary

The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.

Conditions Studied

Interventions

  • DRUG placebo
  • DRUG bosentan

Study Locations (20)

Other

  • The Prince Charles Hospital - Brisbane
  • Royal Prince Albert Hospital - Camperdown
  • St. Vincent's Hospital - Darlinghurst
  • General Hospital of Vienna - Vienna
  • UZ Gasthuisberg - Leuven
  • Queen Mary Hospital - Hong Kong
  • Interni klinika VFN - Prague
  • Marseille-Timone - Marseille

Alberta

  • University of Calgary - Calgary
  • University of Alberta - Edmonton

Ontario

  • Victoria Medical Centre - Hamilton
  • Toronto General Hospital - Toronto

Alabama

  • University of Alabama-Birmingham - Birmingham

California

  • Harbor UCLA Medical Center - Torrance

Massachusetts

  • Tufts- New England Medical Center - Boston

Michigan

  • University of Michigan - Ann Arbor

Ohio

  • Cleveland Clinic Foundation - Cleveland

Trial Details

FieldValue
Enrollment Target 185 participants
Start Date 2004-04
Est. Completion 2011-02
Phase Phase 3
Actelion

63 total trials

What the finished NCT00091715 record still lists

NCT00091715 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 611-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (70% lower).

The record links to 1 condition, with Pulmonary Hypertension appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT00091715 names 20 study sites across 11 states, led by Other, Alberta, Ontario.

Frequently Asked Questions

What is clinical trial NCT00091715 about?

NCT00091715 is a clinical study titled "Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II". The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.

What is the current status of trial NCT00091715?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 185 participants. The study started on 2004-04. Estimated completion is 2011-02.

What conditions does trial NCT00091715 study?

This clinical trial studies the following conditions: Pulmonary Hypertension.

What interventions are being tested in trial NCT00091715?

The interventions under investigation include: placebo (DRUG), bosentan (DRUG).

Who is sponsoring clinical trial NCT00091715?

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

Where is trial NCT00091715 being conducted?

This trial has 20 study locations across Alabama, California, Massachusetts, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pulmonary Hypertension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00091715's enrollment target sits among peer trials

185 24th of 72 higher than 49 of 72 other Pulmonary Hypertension trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pulmonary Hypertension 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 NCT00091715, the US trial registry maintained by the National Library of Medicine. NCT00091715 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.