A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension

Condition(s) targeted: Hypertension, Pulmonary

Intervention: sildenafil (Drug); sildenafil (Drug); placebo (Drug); sildenafil (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

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

To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.

Official title: A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in exercise capacity, as measured by distance walked in six minutes (6-Minute Walk test).

Secondary outcome:

Change from baseline in mean pulmonary arterial pressure

Time from randomisation to the first occurrence of clinical worsening (death or lung transplantation or hospitalisation due to pulmonary hypertension or initiation of prostacyclin therapy or initiation of bosentan therapy)

Change from baseline in the BORG dyspnoea score

Change from baseline in pulmonary hypertension criteria for functional capacity and therapeutic class

Change from baseline in the 8 dimensions of SF-36 (Physical functioning, Role functioning, Bodily pain, General health, Vitality, Social functioning, Mental health and Reported health transition)

Change from baseline at Weeks 4 and 12 in the 5 dimensions of ED5Q (Mobility, Self care, Usual Activities, Pain/Discomfort and Anxiety/Depression)

Patient overall preference assessment

Change in Chronic Use of Background Therapy for Pulmonary Arterial Hypertension

Change from baseline in hemodynamic parameters

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

Criteria:

Inclusion Criteria: Included patients had primary pulmonary arterial hypertension, pulmonary hypertension secondary to connective tissue disease, or pulmonary hypertension with surgical repair at least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmHg and a pulmonary artery wedge pressure of less than or equal to 15 mmHg at rest, via right heart catheterisation within 21 days prior to randomisation; and a baseline 6-Minute Walk test distance of 100 m to 450 m. Exclusion Criteria: Subjects with congenital heart disease, pulmonary hypertension due to thromboembolism, HIV, chronic obstructive airway disease, congestive heart failure or schistosomiasis; subjects with significant (ie > 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation; and acutely decompensated heart failure within the previous 30 days; subjects with pulmonary hypertension secondary to any other etiology other than those specified in the inclusion criteria.

Pfizer Investigational Site, Bruxelles 1070, Belgium

Pfizer Investigational Site, Leuven 3000, Belgium

Pfizer Investigational Site, Prague 4 140 00, Czech Republic

Pfizer Investigational Site, Prague 4 140 21, Czech Republic

Pfizer Investigational Site, Kobenhavn 2100, Denmark

Pfizer Investigational Site, Clamart 92141, France

Pfizer Investigational Site, Berlin 13353, Germany

Pfizer Investigational Site, Giessen 35385, Germany

Pfizer Investigational Site, Giessen 35392, Germany

Pfizer Investigational Site, Hannover 30625, Germany

Pfizer Investigational Site, Leipzig 04103, Germany

Pfizer Investigational Site, Shatin N T, Hong Kong

Pfizer Investigational Site, Petach Tikva 49100, Israel

Pfizer Investigational Site, Tel Hashomer 52621, Israel

Pfizer Investigational Site, Bologna 40138, Italy

Pfizer Investigational Site, Pisa 56124, Italy

Pfizer Investigational Site, Pisa 56126, Italy

Pfizer Investigational Site, Suwon 442-721, Korea, Republic of

Pfizer Investigational Site, Kuala Lumpur 59100, Malaysia

Pfizer Investigational Site, Tlalpan, Mexico

Pfizer Investigational Site, Amsterdam 1081 HV, Netherlands

Pfizer Investigational Site, Oslo NO-0027, Norway

Pfizer Investigational Site, Katowice 40-057, Poland

Pfizer Investigational Site, Warszawa 01-138, Poland

Pfizer Investigational Site, Warszawa 03-709, Poland

Pfizer Investigational Site, Zabrze 41-800, Poland

Pfizer Investigational Site, Singapore 168752, Singapore

Pfizer Investigational Site, Cape Town 7700, South Africa

Pfizer Investigational Site, Johannesburg 2193, South Africa

Pfizer Investigational Site, Parow, South Africa

Pfizer Investigational Site, Barcelona 08035, Spain

Pfizer Investigational Site, Barcelona 08036, Spain

Pfizer Investigational Site, Madrid 28041, Spain

Pfizer Investigational Site, Goteborg 413 45, Sweden

Pfizer Investigational Site, Molndal 431 80, Sweden

Pfizer Investigational Site, Glasgow G11 6NT, United Kingdom

Pfizer Investigational Site, High Heaton, Newcastle-upon-tyne NE7 7DW, United Kingdom

Pfizer Investigational Site, Birmingham, Alabama 35233, United States

Pfizer Investigational Site, Birmingham, Alabama 35294-0006, United States

Pfizer Investigational Site, Birmingham, Alabama 35294, United States

Pfizer Investigational Site, La Jolla, California 92037, United States

Pfizer Investigational Site, La Jolla, California 92093, United States

Pfizer Investigational Site, Los Angeles, California 90033, United States

Pfizer Investigational Site, Los Angeles, California 90024, United States

Pfizer Investigational Site, Los Angeles, California 90095, United States

Pfizer Investigational Site, San Diego, California 92037, United States

Pfizer Investigational Site, Torrance, California 90502, United States

Pfizer Investigational Site, Torrance, California 90509, United States

Pfizer Investigational Site, Papworth Everard, Cambridgeshire CB3 8RE, United Kingdom

Pfizer Investigational Site, Aurora, Colorado 80010, United States

Pfizer Investigational Site, Denver, Colorado 80262, United States

Pfizer Investigational Site, Chicago, Illinois 60612, United States

Pfizer Investigational Site, Shreveport, Louisiana 71103, United States

Pfizer Investigational Site, Baltimore, Maryland 21205, United States

Pfizer Investigational Site, Boston, Massachusetts 02111, United States

Pfizer Investigational Site, Ann Arbor, Michigan 48109, United States

Pfizer Investigational Site, Rochester, Minnesota 55905, United States

Pfizer Investigational Site, Darlinghurst, New South Wales 2010, Australia

Pfizer Investigational Site, New York, New York 10032, United States

Pfizer Investigational Site, Durham, North Carolina 27710, United States

Pfizer Investigational Site, Budapest, Pest 1529, Hungary

Pfizer Investigational Site, Sao Paulo, SP 05403-900, Brazil

Pfizer Investigational Site, Sheffield, South Yorkshire S10 2JF, United Kingdom

Pfizer Investigational Site, Nashville, Tennessee 37232, United States

Pfizer Investigational Site, Houston, Texas 77030, United States

Pfizer Investigational Site, Melbourne, Victoria 3004, Australia

Pfizer Investigational Site, Milwaukee, Wisconsin 53215, United States

Pfizer Investigational Site, Zalaegerszeg, Zala 8900, Hungary

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

Starting date: October 2002
Last updated: April 21, 2015