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NCT00644605 Clinical Trial

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

Hypertension, Pulmonary Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00644605
Other study ID # A1481140
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2002
Est. completion date November 2003

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 275
Est. completion date November 2003
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• sildenafil
sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
• sildenafil
sildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID
• placebo
placebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
• sildenafil
sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks

Locations
Country Name City State
Australia Pfizer Investigational Site Darlinghurst New South Wales
Australia Pfizer Investigational Site Melbourne Victoria
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Leuven
Brazil Pfizer Investigational Site Sao Paulo SP
Czechia Pfizer Investigational Site Prague 4
Czechia Pfizer Investigational Site Prague 4
Denmark Pfizer Investigational Site Kobenhavn
France Pfizer Investigational Site Clamart
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Giessen
Germany Pfizer Investigational Site Giessen
Germany Pfizer Investigational Site Hannover
Germany Pfizer Investigational Site Leipzig
Hong Kong Pfizer Investigational Site Shatin N T
Hungary Pfizer Investigational Site Budapest Pest
Hungary Pfizer Investigational Site Zalaegerszeg Zala
Israel Pfizer Investigational Site Petach Tikva
Israel Pfizer Investigational Site Tel Hashomer
Italy Pfizer Investigational Site Bologna
Italy Pfizer Investigational Site Pisa
Italy Pfizer Investigational Site Pisa
Korea, Republic of Pfizer Investigational Site Suwon
Malaysia Pfizer Investigational Site Kuala Lumpur
Mexico Pfizer Investigational Site Tlalpan
Netherlands Pfizer Investigational Site Amsterdam
Norway Pfizer Investigational Site Oslo
Poland Pfizer Investigational Site Katowice
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Zabrze
Singapore Pfizer Investigational Site Singapore
South Africa Pfizer Investigational Site Cape Town
South Africa Pfizer Investigational Site Johannesburg
South Africa Pfizer Investigational Site Parow
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Madrid
Sweden Pfizer Investigational Site Goteborg
Sweden Pfizer Investigational Site Molndal
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site HIGH Heaton, Newcastle-upon-tyne
United Kingdom Pfizer Investigational Site Papworth Everard Cambridgeshire
United Kingdom Pfizer Investigational Site Sheffield South Yorkshire
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site La Jolla California
United States Pfizer Investigational Site La Jolla California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Rochester Minnesota
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Shreveport Louisiana
United States Pfizer Investigational Site Torrance California
United States Pfizer Investigational Site Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Czechia,  Denmark,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Norway,  Poland,  Singapore,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in exercise capacity, as measured by distance walked in six minutes (6-Minute Walk test). Week 12
Secondary Change from baseline in mean pulmonary arterial pressure Week 12
Secondary 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) Week 0 to 12
Secondary Change from baseline in the BORG dyspnoea score Week 12
Secondary Change from baseline in pulmonary hypertension criteria for functional capacity and therapeutic class Week 12
Secondary 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) Week 4 and Week 12
Secondary Change from baseline at Weeks 4 and 12 in the 5 dimensions of ED5Q (Mobility, Self care, Usual Activities, Pain/Discomfort and Anxiety/Depression) Week 4 and Week 12
Secondary Patient overall preference assessment Week 12
Secondary Change in Chronic Use of Background Therapy for Pulmonary Arterial Hypertension throughout the study
Secondary Change from baseline in hemodynamic parameters Week 12
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Completed NCT02576002 - Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension) N/A
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