Clinical trial NCT00323297: Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension
Official title: A Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-05-09
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* PAH secondary to any aetiology including congenital heart disease other than those specified in the inclusion criteria
* 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.

Primary outcomes:
measure: Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF
timeFrame: Week 12
measure: Clinical Worsening Events
timeFrame: Week 12
measure: Change From Baseline in Borg Dyspnea Score at Week 12
timeFrame: Week 12
measure: One Year Survival Probability From the Start of Sildenafil Treatment.
timeFrame: One year from the time of starting sildenafil
measure: One Year Survival From the Start of Sildenafil Treatment.
timeFrame: One year from the time of starting sildenafil
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: West Los Angeles VA Healthcare, Pulmonary Hypertension Program
state: California
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Darlinghurst
country: Australia
facility: St. Vincents Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 4
country: Czechia
facility: Institut klinicke a experimentalni mediciny, Klinika kardiologie
city: Lille
country: France
facility: Clinique des Maladies Respiratoires
city: Lille
country: France
facility: Hopital Claude Huriez
city: Vandoeuvre Les Nancy
country: France
facility: Hopital Adules Brabois
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin, Klinik fuer Innere Medizin
city: Coburg
country: Germany
facility: II. Medizinische Klinik, Kardiologie, Angiologie und Pneumologie
city: Essen
country: Germany
facility: Universitaetsklinikum Essen, Zentrum fuer Innere Medizin, Klinik fuer Kardiologie
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH, Standort Giessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Homburg
country: Germany
facility: Universitaetsklinikum des Saarlandes, Innere Medizin V
city: Leipzig
country: Germany
facility: Medizinische Klinik und Poliklinik I, Universitaetsklinikum Leipzig
city: Muenchen
country: Germany
facility: Med. Klinik u. Poliklinik I der LMU Muenchen, Klinikum Grosshadern
city: Nuernberg
country: Germany
facility: Praxis fuer Innere Medizin, Kardiologie und Angiologie
city: Wuerzburg
country: Germany
facility: Missionsaerztliche Klinik Wuerzburg, Gemeinnuetzige Gesellschaft mbH
city: Haidari
country: Greece
facility: Attikon Hospital
state: Athens
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Centre
city: Napoli
country: Italy
facility: Cardiologia, Azienda Ospedaliera Monaldi, Seconda Università di Napoli
city: Roma
country: Italy
facility: Unita' di Ipertensione Polmonare, Dipartimento di Scienze Respiratorie e Cardiovascolari
city: Taipei
country: Taiwan
facility: Department of Surgery, National Taiwan University Hospital
city: Papworth Everard
country: United Kingdom
facility: PVDU
state: Cambridgeshire
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.