Study Stopped
This study was terminated at the recommendation of an independent Data Monitoring Committee. The decision was not based on any safety concerns.
To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
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)
2 other identifiers
interventional
130
17 countries
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2008
Typical duration for phase_4
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2007
CompletedFirst Posted
Study publicly available on registry
February 2, 2007
CompletedStudy Start
First participant enrolled
April 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2010
CompletedResults Posted
Study results publicly available
May 17, 2011
CompletedDecember 22, 2020
December 1, 2020
2.1 years
January 31, 2007
April 22, 2011
December 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Total Distance Walked During 6-Minute Walk Test (6MWT) at Week 12
6 MWT was 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.
Baseline and Week 12
Secondary Outcomes (7)
Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Week 12
Baseline and Week 12
Number of Participants With Clinical Worsening
Baseline through Week 12
Number of Participants With Change From Baseline in PAH Criteria for Functional Capacity and Therapeutic Class at Week 12
Baseline and Week 12
Change From Baseline in B-Type Natriuretic Peptide (BNP) at Week 12
Baseline and Week 12
Change From Baseline in Pro-BNP at Week 12
Baseline and Week 12
- +2 more secondary outcomes
Study Arms (4)
Sildenafil High dose
EXPERIMENTALSildenafil Low dose
EXPERIMENTALSildenafil medium dose
EXPERIMENTALSildenafil - Open label Phase
EXPERIMENTALOpen label extension from week 12 to week 24.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, 85013, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Atlanta Institute for Medical Research, Inc.
Decatur, Georgia, 30030, United States
Chicago Heart Institute
Elk Grove Village, Illinois, 60007, United States
The Care Group, LLC
Indianapolis, Indiana, 46260, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Mid Carolina Cardiology
Charlotte, North Carolina, 28204, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
Baylor College of Medicine Pulmonary Section
Houston, Texas, 77030, United States
St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
University of Utah Sciences Center
Salt Lake City, Utah, 84132, United States
CJW Chippenham Medical Center
Richmond, Virginia, 23225, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23225, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, 23225, United States
Cardiovascular Associates of Virginia
Richmond, Virginia, 23230, United States
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-909, Brazil
Peta mnogoprofilna bolnitsa za aktivno lechenie, Klinika po kardiologia
Sofia, 1233, Bulgaria
Mnogoprofilna bolnitsa za aktivno lechenie i speshna meditsina "N.I.Pirogov"
Sofia, 1606, Bulgaria
Beijing Shijitan Hospital
Beijing, 100038, China
Shanghai Pulmonology Hospital
Shanghai, 200433, China
Attikon Hospital
Haidari, Athens, 12462, Greece
Care Hospital, The Institute of Medical Sciences
Hyderabad, Andhra Pradesh, 500 001, India
Mehta Hospital & Cardiopulmonary Care Center
Ahmedabad, Gujarat, 380 054, India
Bankers Heart Institute
Vadodara, Gujarat, 390 015, India
St. John's Medical College Hospital
Bangalore, Karnataka, 560 034, India
Metro Multispeciality Hospital
Noida, Uttar Pradesh, 201301, India
IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Unita' di Ipertensione Polmonare, Dipartimento di Scienze Respiratorie e Cardiovascolari
Roma, 00161, Italy
P. Stradins Clinical University Hospital / Latvian Centre of Cardilogy
Riga, LV - 1002, Latvia
National Heart Institute
Kuala Lumpur, 50400, Malaysia
VU Medisch Centrum / afdeling Longziekten
Amsterdam, 1081 HV, Netherlands
Erasmus MC
Rotterdam, 3015 GE, Netherlands
Philippine General Hospital
Manila, 1000, Philippines
Philippine Heart Center
Quezon City, 1100, Philippines
Krakowski Szpital Specjalistyczny Im. Jana Pawla II w Krakowie
Krakow, 31-202, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Slaskie Centrum Chorob Serca
Zabrze, 41-800, Poland
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes
Timișoara, Timiș County, Romania
Spitalul Clinic de Pneumoftiziologie
Iași, 700115, Romania
Scientific Center of Cardiovascular surgery n.a. A.N.Bakoulev RAMS
Moscow, 117931, Russia
Scientific Center of Cardiovascular surgery n.a. A.N.Bakoulev RAMS
Moscow, 121552, Russia
Division of Rheumatology Allergy and Immunology, Department of Medicine, Faculty of Medicine
Amphoe Mueang, Changwat Khon Kaen, 40002, Thailand
Department of Medicine,
Bangkok, 10330, Thailand
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY, United Kingdom
Room 224A Sir William Leech Centre
Newcastle upon Tyne, TYNE and WEAR, NE7 7DN, United Kingdom
Related Publications (1)
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.
PMID: 28228114DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The trial was not designed to demonstrate the equivalence of doses and due to premature study termination, the resulting sample size was not adequately powered to show superiority.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2007
First Posted
February 2, 2007
Study Start
April 8, 2008
Primary Completion
May 25, 2010
Study Completion
May 25, 2010
Last Updated
December 22, 2020
Results First Posted
May 17, 2011
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.