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NCT00147199 · ClinicalTrials.gov registry record · Phase 3

Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)

A Phase 3 study of Pulmonary Hypertension, sponsored by United Therapeutics.

Completed
Registry status
Phase 3
Development phase
235
Enrollment target
20
Study locations

NCT00147199 is a Phase 3 study of Pulmonary Hypertension that has completed, run by United Therapeutics. The registered enrollment target is 235 participants, below the 610-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT00147199, a Phase 3 study of Pulmonary Hypertension, has completed, sponsored by United Therapeutics.

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

Study Summary

This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.

Conditions Studied

Interventions

  • DRUG Inhaled treprostinil
  • DRUG Placebo inhalation solution

Study Locations (20)

Other

  • Medical University Graz - Graz
  • Universite Libre de Bruxelles - Brussels
  • University Hospital Gasthuisburg - Leuven
  • Hospital Antoine Beclere - Paris

California

  • UCSD Medical center - La Jolla
  • UCLA Medical Center - Torrance

Alabama

  • University of Alabama - Birmingham

Arizona

  • University of Arizona - Tucson

Colorado

  • University of Colorado - Aurora

Florida

  • Orlando Heart Center - Orlando

Kansas

  • Kansas University Medical Center - Kansas City

Maryland

  • Johns Hopkins University - Baltimore

Trial Details

FieldValue
Enrollment Target 235 participants
Start Date 2005-06
Est. Completion 2007-10
Phase Phase 3

Sponsor

United Therapeutics

63 total trials

What the Registry Record Tells You About NCT00147199

The ClinicalTrials.gov registry entry for NCT00147199 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 610-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (61% lower). The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.

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

NCT00147199 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Other, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT00147199 about?

NCT00147199 is a clinical study titled "Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)". This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.

What is the current status of trial NCT00147199?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2005-06. Estimated completion is 2007-10.

What conditions does trial NCT00147199 study?

This clinical trial studies the following conditions: Pulmonary Hypertension.

What interventions are being tested in trial NCT00147199?

The interventions under investigation include: Inhaled treprostinil (DRUG), Placebo inhalation solution (DRUG).

Who is sponsoring clinical trial NCT00147199?

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

Where is trial NCT00147199 being conducted?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.