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NCT00323297 · ClinicalTrials.gov registry record · Phase 4

Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension

A Phase 4 study of Pulmonary Arterial Hypertension, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

Completed
Registry status
Phase 4
Development phase
105
Enrollment target
20
Study locations

NCT00323297 is a Phase 4 study of Pulmonary Arterial Hypertension that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 105 participants, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT00323297, a Phase 4 study of Pulmonary Arterial Hypertension, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

COMPLETED
Registry status
Phase 4
Development phase
105 participants
Enrollment target
20
Study locations

Study Summary

To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.

Interventions

  • OTHER Placebo
  • DRUG Bosentan
  • DRUG Sildenafil Citrate

Study Locations (20)

Other

  • Vseobecna fakultni nemocnice v Praze - Prague
  • Institut klinicke a experimentalni mediciny, Klinika kardiologie - Prague
  • Clinique des Maladies Respiratoires - Lille
  • Hopital Claude Huriez - Lille
  • Hopital Adules Brabois - Vandœuvre-lès-Nancy
  • Unfallkrankenhaus Berlin, Klinik fuer Innere Medizin - Berlin
  • II. Medizinische Klinik, Kardiologie, Angiologie und Pneumologie - Coburg
  • Universitaetsklinikum Essen, Zentrum fuer Innere Medizin, Klinik fuer Kardiologie - Essen
  • Universitaetsklinikum Giessen und Marburg GmbH, Standort Giessen - Giessen
  • Medizinische Hochschule Hannover - Hanover
  • Universitaetsklinikum des Saarlandes, Innere Medizin V - Homburg
  • Medizinische Klinik und Poliklinik I, Universitaetsklinikum Leipzig - Leipzig

Texas

  • Baylor College of Medicine - Houston
  • The Methodist Hospital - Houston
  • Diagnostics Research Group - San Antonio

California

  • West Los Angeles VA Healthcare, Pulmonary Hypertension Program - Los Angeles

Michigan

  • Henry Ford Hospital - Detroit

Pennsylvania

  • Allegheny General Hospital - Pittsburgh

New South Wales

  • St. Vincents Hospital - Darlinghurst

Queensland

  • The Prince Charles Hospital - Chermside

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2006-09
Est. Completion 2013-08
Phase Phase 4

What the Registry Record Tells You About NCT00323297

The ClinicalTrials.gov registry entry for NCT00323297 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (77% lower). The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00323297 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Texas, California.

Frequently Asked Questions

What is clinical trial NCT00323297 about?

NCT00323297 is a clinical study titled "Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension". To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.

What is the current status of trial NCT00323297?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 105 participants. The study started on 2006-09. Estimated completion is 2013-08.

What conditions does trial NCT00323297 study?

This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.

What interventions are being tested in trial NCT00323297?

The interventions under investigation include: Placebo (OTHER), Bosentan (DRUG), Sildenafil Citrate (DRUG).

Who is sponsoring clinical trial NCT00323297?

This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00323297 being conducted?

This trial has 20 study locations across California, Michigan, Pennsylvania, Texas, New South Wales. 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

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