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

NCT00323297 | Completed Phase 4 Results DMC

• 3 other identifiers: A14812432006-001464-23PATHWAYS
• Study Type: interventional
• Target: 105
• Locations: 10 countries
• Sites: 30

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12

  6MWT is the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.

  Week 12

Secondary Outcomes (5)

• Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF

  Week 12

• Clinical Worsening Events

  Week 12

• Change From Baseline in Borg Dyspnea Score at Week 12

  Week 12

• One Year Survival Probability From the Start of Sildenafil Treatment.

  One year from the time of starting sildenafil

• One Year Survival From the Start of Sildenafil Treatment.

  One year from the time of starting sildenafil

Study Arms (2)

placebo

PLACEBO COMPARATOR

Drug: Bosentan; Other: Placebo

Active

EXPERIMENTAL

Drug: Bosentan; Drug: Sildenafil Citrate

Interventions

Bosentan DRUG

Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)

placebo

Placebo OTHER

Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)

placebo

Sildenafil Citrate DRUG

Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 18 and over above with PAH and for which bosentan therapy is indicated according to national license
• Subjects with a mean pulmonary artery pressure of \>25mmHg and a pulmonary artery wedge pressure of \<15mmHg at rest via right heart catheterization within 3 years prior to randomization.
• Subjects whose baseline 6 Minute Walk Test distance is \>100m and \< 450m.

You may not qualify if:

• Subjects whose 6 Minute Walk Test may be limited by conditions other than PAH related dyspnoea or fatigue eg. claudication from vascular insufficiency or arthritis.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (30)

West Los Angeles VA Healthcare, Pulmonary Hypertension Program

Los Angeles, California, 90073, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

St. Vincents Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

Institut klinicke a experimentalni mediciny, Klinika kardiologie

Prague, 140 21, Czechia

Location

Clinique des Maladies Respiratoires

Lille, 59037, France

Location

Hopital Claude Huriez

Lille, 59037, France

Location

Hopital Adules Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Unfallkrankenhaus Berlin, Klinik fuer Innere Medizin

Berlin, 12683, Germany

Location

II. Medizinische Klinik, Kardiologie, Angiologie und Pneumologie

Coburg, 96450, Germany

Location

Universitaetsklinikum Essen, Zentrum fuer Innere Medizin, Klinik fuer Kardiologie

Essen, 45122, Germany

Location

Universitaetsklinikum Giessen und Marburg GmbH, Standort Giessen

Giessen, 35392, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitaetsklinikum des Saarlandes, Innere Medizin V

Homburg, 66421, Germany

Location

Medizinische Klinik und Poliklinik I, Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Location

Med. Klinik u. Poliklinik I der LMU Muenchen, Klinikum Grosshadern

München, 81377, Germany

Location

Praxis fuer Innere Medizin, Kardiologie und Angiologie

Nuremberg, 90402, Germany

Location

Missionsaerztliche Klinik Wuerzburg, Gemeinnuetzige Gesellschaft mbH

Würzburg, 97067, Germany

Location

Attikon Hospital

Haidari, Athens, 12462, Greece

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Rabin Medical Centre

Petah Tikva, 49100, Israel

Location

Cardiologia, Azienda Ospedaliera Monaldi, Seconda Università di Napoli

Napoli, 80131, Italy

Location

Unita' di Ipertensione Polmonare, Dipartimento di Scienze Respiratorie e Cardiovascolari

Roma, 00161, Italy

Location

Department of Surgery, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

PVDU

Papworth Everard, Cambridgeshire, CB23 3RE, United Kingdom

Location

Related Publications (1)

• Vizza CD, Jansa P, Teal S, Dombi T, Zhou D. Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial. BMC Cardiovasc Disord. 2017 Sep 6;17(1):239. doi: 10.1186/s12872-017-0674-3.

  PMID: 28874133 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Bosentan; Sildenafil Citrate

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 9, 2006
• Study Start: September 1, 2006
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 1, 2021
• Results First Posted: November 19, 2013

Record last verified: 2021-01

Locations

IT (2); GB (1); CZ (2); AU (2); DE (10); GR (1); IL (2); TW (1); US (6); FR (3)