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

PHASE4CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

Bosentan

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

OTHER

Placebo

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

DRUG

Bosentan

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

DRUG

Sildenafil Citrate

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

Trial Locations (30)

100

Department of Surgery, National Taiwan University Hospital, Taipei

2010

St. Vincents Hospital, Darlinghurst

4032

The Prince Charles Hospital, Chermside

12462

Attikon Hospital, Haidari

12683

Unfallkrankenhaus Berlin, Klinik fuer Innere Medizin, Berlin

15212

Allegheny General Hospital, Pittsburgh

30625

Medizinische Hochschule Hannover, Hanover

31096

Rambam Medical Center, Haifa

35392

Universitaetsklinikum Giessen und Marburg GmbH, Standort Giessen, Giessen

45122

Universitaetsklinikum Essen, Zentrum fuer Innere Medizin, Klinik fuer Kardiologie, Essen

48202

Henry Ford Hospital, Detroit

49100

Rabin Medical Centre, Petah Tikva

54511

Hopital Adules Brabois, Vandœuvre-lès-Nancy

59037

Clinique des Maladies Respiratoires, Lille

Hopital Claude Huriez, Lille

66421

Universitaetsklinikum des Saarlandes, Innere Medizin V, Homburg

77030

Baylor College of Medicine, Houston

The Methodist Hospital, Houston

78229

Diagnostics Research Group, San Antonio

80131

Cardiologia, Azienda Ospedaliera Monaldi, Seconda Università di Napoli, Napoli

81377

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

90073

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

90402

Praxis fuer Innere Medizin, Kardiologie und Angiologie, Nuremberg

96450

II. Medizinische Klinik, Kardiologie, Angiologie und Pneumologie, Coburg

97067

Missionsaerztliche Klinik Wuerzburg, Gemeinnuetzige Gesellschaft mbH, Würzburg

128 08

Vseobecna fakultni nemocnice v Praze, Prague

140 21

Institut klinicke a experimentalni mediciny, Klinika kardiologie, Prague

04103

Medizinische Klinik und Poliklinik I, Universitaetsklinikum Leipzig, Leipzig

00161

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

CB23 3RE

PVDU, Papworth Everard

All Listed Sponsors
lead

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

INDUSTRY

NCT00323297 - Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension | Biotech Hunter | Biotech Hunter