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NCT00159887 Clinical Trial

Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension

Pulmonary Hypertension Clinical Trial

Official title:
A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00159887
Other study ID # A1481142
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 2002
Est. completion date February 2007

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

Clinical Trial Summary

Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension

Recruitment information / eligibility
Status Completed
Enrollment 260
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with PAH who had completed the 12 week pivotal study Exclusion Criteria: - Any other patients with PAH that had not been included into the pivotal study

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sildenafil citrate

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 Cedex
Germany Pfizer Investigational Site Giessen
Germany Pfizer Investigational Site Hannover
Germany Pfizer Investigational Site Leipzig
Hong Kong Pfizer Investigational Site Shatin NT
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Zalaegerszeg
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
Malaysia Pfizer Investigational Site Petaling Jaya
Mexico Pfizer Investigational Site Tlalpan Mexico DF
Mexico Pfizer Investigational Site Tlalpan Mexico DF
Netherlands Pfizer Investigational Site Amsterdam
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Zabrze
Singapore Pfizer Investigational Site Singapore
South Africa Pfizer Investigational Site Parktown
South Africa Pfizer Investigational Site Parktown West
South Africa Pfizer Investigational Site Parow Western Cape
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Madrid
Sweden Pfizer Investigational Site Goteborg
United Kingdom Pfizer Investigational Site Cambridge
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site Newcastle Upon Tyne Tyne And Wear
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 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 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 Los Angeles California
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site Nashville Tennessee
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 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,  Poland,  Singapore,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety
Primary Standard safety data
Primary Efficacy
Primary 6-Minute Walk Test
Primary BORG Dyspnoea Score
Primary WHO Functional Class
Primary Quality of Life SF-36 and EQ-5D
See also
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