Clinical trial NCT02060487: Effects of Oral Sildenafil on Mortality in Adults With PAH
Official title: A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension
pulmonary hypertension
PAH
sildenafil
revatio
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-02-12
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day \[TID\]). In addition, the relative effects on clinical worsening and 6-minute walking distance (6MWD) will be assessed.


Eligibility criteria: Inclusion Criteria:

Subjects ≥ 18 \<75 years of age with any of the following conditions:

* Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)
* PAH secondary to connective tissue disease
* PAH with surgical repair (at least 5 years previously) of atrial septal defect (ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and aorto-pulmonary window
* PAH diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization
* Functional Class II-IV; Baseline 6MWD ≥ 50 m.

Exclusion Criteria:

* Significant (ie, \>2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation
* History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation
* History of pulmonary embolism; History of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with impairment of lung function
* No prior long term treatment with PDE-5 inhibitors
* Treatment with bosentan OR riociguat within 3 months of randomization
* Current treatment with nitrates or nitric oxide

Primary outcomes:
measure: Overall Survival
timeFrame: Day 1 of study treatment up to date of death (within a maximum duration of 2102 days)
Secondary outcomes:
measure: Number of Participants With Clinical Worsening Events
timeFrame: Day 1 of study treatment up to date of clinical worsening event (within a maximum duration of 2080 days)
measure: Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Investigational Drug Services
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Grand Rapids
country: United States
facility: Frederik Meijer Heart & Vascular Institute Cardiovascular Research
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Butterworth Hospital IDS Pharmacy
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Heart & Lung Specialized Care Clinic
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group - Pulmonary Division
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Wooster
country: United States
facility: Robert V. Sibilia MD, Inc.
state: Ohio
city: Dallas
country: United States
facility: UT Southwestern Medical School
state: Texas
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Australian Respiratory and Sleep Medicine Institute
state: South Australia
city: Yvoir
country: Belgium
facility: University Hospital of Mont-Godinne
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center of the Republic of Srpska
state: B&h/republic OF Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University Sarajevo
state: Bosnia AND Herzegovina/canton Sarajevo
city: Tuzla
country: Bosnia and Herzegovina
facility: Health Institution Special Hospital "Medical Institute Bayer"
state: Canton Tuzla
city: Mostar
country: Bosnia and Herzegovina
facility: University Clinical Hospital Mostar
state: Herzegovina-neretva Canton
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
state: Czech Republic
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 4
country: Czechia
facility: Institut Klinicke a Experimentalni Mediciny
city: Berlin
country: Germany
facility: DRK Kliniken Berlin, Westend
city: Dresden
country: Germany
facility: Universitaetsklinikum der TU Dresden
city: Dresden
country: Germany
facility: Universitatsklinikum TU Dresden
city: Greifswald
country: Germany
facility: Universitaetsmedizin Greifswald
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Thoraxklinik am Universitaetsklinikum Heidelberg
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Athens
country: Greece
facility: University General Hospital of Athens "Attikon"
state: Attiki
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis
state: Evros
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Thessaloniki
country: Greece
facility: University General Hospital of Thessaloniki AHEPA
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Johor Bahru
country: Malaysia
facility: Hospital Sultanah Aminah
state: Johor
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
state: Kedah
city: Kajang
country: Malaysia
facility: Hospital Serdang
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Monterrey
country: Mexico
facility: Centro De Prevencion Y Rehabilitacion De Enfermedades Pulmonares Crónicas
state: Nuevo LEÓN
city: Merida
country: Mexico
facility: Centro de Desarrollo Biomedico
state: Yucatan
city: Queretaro
country: Mexico
facility: Centro de Estudios Clinicos de Queretaro S.C.
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4
city: Cluj-Napoca
country: Romania
facility: Institutul Inimii ,,Niculae Stancioiu" Cluj Napoca
city: Targu-Mures
country: Romania
facility: Institutul de Urgenta pentru Boli Cardiovasculare si Transplant Targu-Mures
city: Kemerovo
country: Russian Federation
facility: FSBI "Research Institute of complex problems of cardiovascular diseases"
city: Moscow
country: Russian Federation
facility: FSBI Scientific Research Institute of Pulmonology of FMBA
city: Novosibirsk
country: Russian Federation
facility: FSBI "E.Meshalkin National medical research center"
city: St. Petersburg
country: Russian Federation
facility: FSBI "V.A. Almazov National Medical Research Center"
city: Sremska Kamenica
country: Serbia
facility: Institute for Cardiovascular disease of Vojvodina
state: Vojvodina
city: Sremska Kamenica
country: Serbia
facility: Institute for Pulmonary Diseases of Vojvodina
state: Vojvodina
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: University Medical Center Zvezdara
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Singapore
country: Singapore
facility: National University Heart Centre, National University Hospital Singapore (NUHS)
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
city: Johannesburg
country: South Africa
facility: Center of Chest Diseases
state: Gauteng
city: Johannesburg
country: South Africa
facility: Dr PG Williams Practice
state: Gauteng
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´Hebrón
state: Cataluña
city: Pathumwan
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
state: Bangkok
city: Pathumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
state: Bangkok
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
state: Chiang MAI
city: Sripoom Sub-district, Muang
country: Thailand
facility: Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University
state: Chiang MAI
city: Muang District
country: Thailand
facility: Division of Cardiology, Department of Medicine, Faculty of Medicine, Khon Kaen University
state: Khon Kaen
city: Muang District
country: Thailand
facility: Queen Sirikit Heart Center of the Northeast, Khon Kaen University
state: Khon Kaen
city: Muang District
country: Thailand
facility: Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
state: Khon Kaen
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Training and Research Hospital
state: Bakirkoy
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
state: Fatih
city: Istanbul
country: Turkey
facility: Istanbul University Haseki Cardiology Institute
state: Fatih
city: Izmir
country: Turkey
facility: Dokuz Eylul Üniversitesi Tıp Fakültesi Kardiyoloji Bilim Dalı
state: Inciralti
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
state: Pendik
city: Kharkiv,
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo
city: Kyiv
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo Oleksandrivska klinichna likarnia m. Kyieva
city: Kyiv
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo
city: Kyiv
country: Ukraine
facility: Derzhavna ustanova Natsionalnyi naukovyi tsentr
city: M. Dnipro
country: Ukraine
facility: Komunalne pidpryiemstvo "Dnipropetrovskyi oblasnyi klinichnyi tsentr kardiolohii ta kardiokhirurhii"
city: Uzhhorod,
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: