Clinical trial NCT00430716: To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
Official title: A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-02-02
Enrollment: 130
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 demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.


Eligibility criteria: Inclusion Criteria:

* Subjects with PAH (i.e. IPAH or secondary to connective tissue disease or with surgical repair of ASD, VSD, PDA, aorto-pulmonary window) whose baseline six minute walk test distance is \>/= 100 m and \</= 450 m.
* Subjects with a mean pulmonary artery pressure of \>/= 25 mmHg and a pulmonary artery wedge pressure of \</= 15 mmHg at rest via right heart catheterization performed within 12 weeks prior to randomization.

Exclusion Criteria:

* Subjects whose 6 Minute Walk Distance may be limited by conditions other than PAH related dyspnoea or fatigue, e.g. claudication from vascular insufficiency or significant arthritis.
* Subjects who are currently receiving any forms of chronic treatment for PAH such as prostacyclin, PDE-5 inhibitors, endothelin-receptor antagonists, nitrates or nitric oxide donors (e.g. arginine supplement, nicorandil) in any form, protease inhibitors such as ritonavir and saquinavir, ketoconazole, itraconazole, and alpha blockers. Subjects previously receiving any of these drugs must have stopped use for a period of at least 1 month prior to screening, except in the case of bosentan or prostacyclin (3 months).

Primary outcomes:
measure: Change From Baseline in the Total Distance Walked During 6-Minute Walk Test (6MWT) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Week 12
timeFrame: Baseline and Week 12
measure: Number of Participants With Clinical Worsening
timeFrame: Baseline through Week 12
measure: Number of Participants With Change From Baseline in PAH Criteria for Functional Capacity and Therapeutic Class at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in B-Type Natriuretic Peptide (BNP) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Pro-BNP at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in TAPSE Measurement at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in BORG Dyspnoea Score at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists, LTD
state: Arizona
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Decatur
country: United States
facility: Atlanta Institute for Medical Research, Inc.
state: Georgia
city: Elk Grove Village
country: United States
facility: Chicago Heart Institute
state: Illinois
city: Indianapolis
country: United States
facility: The Care Group, LLC
state: Indiana
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Mid Carolina Cardiology
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Houston
country: United States
facility: Baylor College of Medicine Pulmonary Section
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Sciences Center
state: Utah
city: Richmond
country: United States
facility: CJW Chippenham Medical Center
state: Virginia
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond, Inc.
state: Virginia
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialists
state: Virginia
city: Richmond
country: United States
facility: Cardiovascular Associates of Virginia
state: Virginia
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: RS
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
state: SP
city: Sofia
country: Bulgaria
facility: Peta mnogoprofilna bolnitsa za aktivno lechenie, Klinika po kardiologia
city: Sofia
country: Bulgaria
facility: Mnogoprofilna bolnitsa za aktivno lechenie i speshna meditsina "N.I.Pirogov"
city: Beijing
country: China
facility: Beijing Shijitan Hospital
city: Shanghai
country: China
facility: Shanghai Pulmonology Hospital
city: Haidari
country: Greece
facility: Attikon Hospital
state: Athens
city: Hyderabad
country: India
facility: Care Hospital, The Institute of Medical Sciences
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Mehta Hospital & Cardiopulmonary Care Center
state: Gujarat
city: Vadodara
country: India
facility: Bankers Heart Institute
state: Gujarat
city: Bangalore
country: India
facility: St. John's Medical College Hospital
state: Karnataka
city: Noida
country: India
facility: Metro Multispeciality Hospital
state: Uttar Pradesh
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Unita' di Ipertensione Polmonare, Dipartimento di Scienze Respiratorie e Cardiovascolari
city: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital / Latvian Centre of Cardilogy
city: Kuala Lumpur
country: Malaysia
facility: National Heart Institute
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum / afdeling Longziekten
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Manila City
country: Philippines
facility: Philippine General Hospital
city: Quezon City
country: Philippines
facility: Philippine Heart Center
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny Im. Jana Pawla II w Krakowie
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Slaskie Centrum Chorob Serca
city: Timisoara
country: Romania
facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes
state: Timis
city: Iasi
country: Romania
facility: Spitalul Clinic de Pneumoftiziologie
city: Moscow
country: Russian Federation
facility: Scientific Center of Cardiovascular surgery n.a. A.N.Bakoulev RAMS
city: Moscow
country: Russian Federation
facility: Scientific Center of Cardiovascular surgery n.a. A.N.Bakoulev RAMS
city: Amphoe Mueang
country: Thailand
facility: Division of Rheumatology Allergy and Immunology, Department of Medicine, Faculty of Medicine
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Department of Medicine,
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
city: Newcastle Upon Tyne
country: United Kingdom
facility: Room 224A Sir William Leech Centre
state: Tyne and Wear
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Vizza CD, Sastry BK, Safdar Z, Harnisch L, Gao X, Zhang M, Lamba M, Jing ZC. Efficacy of 1, 5, and 20 mg oral sildenafil in the treatment of adults with pulmonary arterial hypertension: a randomized, double-blind study with open-label extension. BMC Pulm Med. 2017 Feb 23;17(1):44. doi: 10.1186/s12890-017-0374-x.