To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: Sildenafil citrate (Drug); Sildenafil citrate (Drug); Sildenafil citrate (Drug); Sildenafil citrate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.

Official title: A Multinational, Multicentre, Randomized, Parallel Group, Double-Blind Study To Assess The Efficacy and Safety Of 1 mg, 5 mg and 20 mg TID of Oral Sildenafil in the Treatment of Subjects Aged 18 Years and Over With Pulmonary Arterial Hypertension (PAH)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The change from baseline in the total distance walked during the 6MWT at Week 12 of the study.

Secondary outcome:

Change from baseline at Week 12 in the pulmonary hypertension criteria for functional capacity and therapeutic class.

Change from baseline at Week 12 in BNP and pro-BNP levels.

Change from baseline at Week 12 in the BORG dyspnoea score.

Change from baseline at Week 12 in mean pulmonary artery pressure (mPAP).

Time from randomization to the first occurrence of clinical worsening defined as death or lung transplantation or hospitalisation due to pulmonary hypertension or initiation of prostacyclin therapy or initiation of bosentan therapy.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 - Subjects with a mean pulmonary artery pressure of >/= 25 mmHg and a pulmonary artery

wedge pressure of 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).

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Leuven 3000, Belgium; Not yet recruiting

Pfizer Investigational Site, Bruxelles 1070, Belgium; Not yet recruiting

Pfizer Investigational Site, Sofia 1202, Bulgaria; Not yet recruiting

Pfizer Investigational Site, Sofia 1233, Bulgaria; Recruiting

Pfizer Investigational Site, Sofia 1606, Bulgaria; Recruiting

Pfizer Investigational Site, Sofia 1309, Bulgaria; Not yet recruiting

Pfizer Investigational Site, Shanghai 200433, China; Recruiting

Pfizer Investigational Site, Beijing 100038, China; Recruiting

Pfizer Investigational Site, Thessaloniki 57010, Greece; Not yet recruiting

Pfizer Investigational Site, Roma 00161, Italy; Recruiting

Pfizer Investigational Site, Pavia 27100, Italy; Recruiting

Pfizer Investigational Site, Roma 00163, Italy; Not yet recruiting

Pfizer Investigational Site, Roma 00152, Italy; Not yet recruiting

Pfizer Investigational Site, Palermo 90147, Italy; Not yet recruiting

Pfizer Investigational Site, Riga LV - 1002, Latvia; Recruiting

Pfizer Investigational Site, Kuala Lumpur 50400, Malaysia; Recruiting

Pfizer Investigational Site, Amsterdam 1081 HV, Netherlands; Recruiting

Pfizer Investigational Site, Rotterdam 3015 GE, Netherlands; Recruiting

Pfizer Investigational Site, Panama City, Panama; Not yet recruiting

Pfizer Investigational Site, Quezon City 1100, Philippines; Recruiting

Pfizer Investigational Site, Manila City 1000, Philippines; Recruiting

Pfizer Investigational Site, Warszawa 01-138, Poland; Not yet recruiting

Pfizer Investigational Site, Krakow 31-202, Poland; Recruiting

Pfizer Investigational Site, Zabrze 41-800, Poland; Not yet recruiting

Pfizer Investigational Site, Iasi 700115, Romania; Recruiting

Pfizer Investigational Site, Moscow 117931, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 121552, Russian Federation; Recruiting

Pfizer Investigational Site, Saint Petersburg 196247, Russian Federation; Not yet recruiting

Pfizer Investigational Site, Bangkok 10330, Thailand; Recruiting

Pfizer Investigational Site, Hyderabad, Andhra Pradesh 500 001, India; Recruiting

Pfizer Investigational Site, Phoenix, Arizona 85013, United States; Completed

Pfizer Investigational Site, Haidari, Athens 12462, Greece; Recruiting

Pfizer Investigational Site, Kallithea, Athens 176 74, Greece; Not yet recruiting

Pfizer Investigational Site, Sacramento, California 95817, United States; Recruiting

Pfizer Investigational Site, Decatur, Georgia 30030, United States; Recruiting

Pfizer Investigational Site, Augusta, Georgia 30912, United States; Recruiting

Pfizer Investigational Site, Ahmedabad, Gujarat 380 054, India; Recruiting

Pfizer Investigational Site, Vadodara, Gujarat 390 015, India; Recruiting

Pfizer Investigational Site, Elk Grove Village, Illinois 60007, United States; Terminated

Pfizer Investigational Site, Indianapolis, Indiana 46260, United States; Completed

Pfizer Investigational Site, Bangalore, Karnataka 560 034, India; Recruiting

Pfizer Investigational Site, Amphoe Mueang, Khon Kaen 40002, Thailand; Recruiting

Pfizer Investigational Site, Syracuse, New York 13210, United States; Not yet recruiting

Pfizer Investigational Site, Norwich, Norfolk NR4 7UY, United Kingdom; Recruiting

Pfizer Investigational Site, Chapel Hill, North Carolina 27599, United States; Recruiting

Pfizer Investigational Site, Charlotte, North Carolina 28204, United States; Recruiting

Pfizer Investigational Site, Huntersville, North Carolina 28078, United States; Recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19140, United States; Recruiting

Pfizer Investigational Site, Hershey, Pennsylvania 17033, United States; Not yet recruiting

Pfizer Investigational Site, Porto Alegre, RS 90610-000, Brazil; Recruiting

Pfizer Investigational Site, Sao Paulo, SP 04012-909, Brazil; Recruiting

Pfizer Investigational Site, Houston, Texas 77030, United States; Recruiting

Pfizer Investigational Site, Timisoara, Timis, Romania; Not yet recruiting

Pfizer Investigational Site, Newcastle Upon Tyne, Tyne and Wear NE7 7DN, United Kingdom; Recruiting

Pfizer Investigational Site, Salt Lake City, Utah 84132, United States; Recruiting

Pfizer Investigational Site, Noida, Uttar Pradesh 201301, India; Recruiting

Pfizer Investigational Site, Richmond, Virginia 23225, United States; Recruiting

Pfizer Investigational Site, Belo Horizonte, mg 30380-090, Brazil; Not yet recruiting

To obtain contact information for a study center near you, click here.

Starting date: April 2008
Ending date: June 2010
Last updated: October 14, 2009