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

January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

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

Study Overview

Status

Completed

Conditions

Pulmonary Hypertension

Intervention / Treatment

Drug: Sildenafil citrate

Study Type

Interventional

Enrollment (Actual)

260

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Darlinghurst, New South Wales, Australia, 2010
    - Pfizer Investigational Site
- Victoria
  - Melbourne, Victoria, Australia, 3004
    - Pfizer Investigational Site
Belgium
- - Bruxelles, Belgium, 1070
    - Pfizer Investigational Site
  - Leuven, Belgium, 3000
    - Pfizer Investigational Site
Brazil
- SP
  - Sao Paulo, SP, Brazil, 05403-900
    - Pfizer Investigational Site
Czechia
- - Prague 4, Czechia, 140 00
    - Pfizer Investigational Site
  - Prague 4, Czechia, 140 21
    - Pfizer Investigational Site
Denmark
- - Kobenhavn, Denmark, 2100
    - Pfizer Investigational Site
France
- - Clamart Cedex, France, 92141
    - Pfizer Investigational Site
Germany
- - Giessen, Germany, 35392
    - Pfizer Investigational Site
  - Hannover, Germany, 30625
    - Pfizer Investigational Site
  - Leipzig, Germany, 04103
    - Pfizer Investigational Site
Hong Kong
- - Shatin NT, Hong Kong
    - Pfizer Investigational Site
Hungary
- - Budapest, Hungary, 1529
    - Pfizer Investigational Site
  - Zalaegerszeg, Hungary, 8900
    - Pfizer Investigational Site
Israel
- - Petach Tikva, Israel, 49100
    - Pfizer Investigational Site
  - Tel Hashomer, Israel, 52621
    - Pfizer Investigational Site
Italy
- - Bologna, Italy, 40138
    - Pfizer Investigational Site
  - Pisa, Italy, 56124
    - Pfizer Investigational Site
  - Pisa, Italy, 56126
    - Pfizer Investigational Site
Korea, Republic of
- - Suwon, Korea, Republic of, 443-721
    - Pfizer Investigational Site
Malaysia
- - Kuala Lumpur, Malaysia, 59100
    - Pfizer Investigational Site
  - Petaling Jaya, Malaysia, 46200
    - Pfizer Investigational Site
Mexico
- DF
  - Tlalpan Mexico, DF, Mexico, 14050
    - Pfizer Investigational Site
- Mexico DF
  - Tlalpan, Mexico DF, Mexico, 14080
    - Pfizer Investigational Site
Netherlands
- - Amsterdam, Netherlands, 1081 HV
    - Pfizer Investigational Site
Poland
- - Warszawa, Poland, 01-138
    - Pfizer Investigational Site
  - Zabrze, Poland, 41-800
    - Pfizer Investigational Site
Singapore
- - Singapore, Singapore, 168752
    - Pfizer Investigational Site
South Africa
- - Parktown, South Africa, 2193
    - Pfizer Investigational Site
  - Parktown West, South Africa, 2193
    - Pfizer Investigational Site
- Western Cape
  - Parow, Western Cape, South Africa, 7505
    - Pfizer Investigational Site
Spain
- - Barcelona, Spain, 08035
    - Pfizer Investigational Site
  - Barcelona, Spain, 08036
    - Pfizer Investigational Site
  - Madrid, Spain, 28041
    - Pfizer Investigational Site
Sweden
- - Goteborg, Sweden, 41345
    - Pfizer Investigational Site
United Kingdom
- - Cambridge, United Kingdom, CB4 9EL
    - Pfizer Investigational Site
  - Glasgow, United Kingdom, G11 6NT
    - Pfizer Investigational Site
- Cambridgeshire
  - Papworth Everard, Cambridgeshire, United Kingdom, CB3 8RE
    - Pfizer Investigational Site
- South Yorkshire
  - Sheffield, South Yorkshire, United Kingdom, S10 2JF
    - Pfizer Investigational Site
- Tyne And Wear
  - Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
    - Pfizer Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Pfizer Investigational Site
  - Birmingham, Alabama, United States, 35294
    - Pfizer Investigational Site
  - Birmingham, Alabama, United States, 35294-0006
    - Pfizer Investigational Site
- California
  - La Jolla, California, United States, 92037
    - Pfizer Investigational Site
  - La Jolla, California, United States, 92093
    - Pfizer Investigational Site
  - Los Angeles, California, United States, 90073
    - Pfizer Investigational Site
  - Los Angeles, California, United States, 90095
    - Pfizer Investigational Site
  - Los Angeles, California, United States, 90033
    - Pfizer Investigational Site
  - Los Angeles, California, United States, 90024
    - Pfizer Investigational Site
  - San Diego, California, United States, 92103-8320
    - Pfizer Investigational Site
  - Torrance, California, United States, 90502
    - Pfizer Investigational Site
- Colorado
  - Denver, Colorado, United States, 80220
    - Pfizer Investigational Site
  - Denver, Colorado, United States, 80262
    - Pfizer Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - Pfizer Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21287
    - Pfizer Investigational Site
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Pfizer Investigational Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Pfizer Investigational Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Pfizer Investigational Site
- New York
  - New York, New York, United States, 10032
    - Pfizer Investigational Site
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Pfizer Investigational Site
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Pfizer Investigational Site
  - Nashville, Tennessee, United States, 37232-5735
    - Pfizer Investigational Site
- Texas
  - Houston, Texas, United States, 77030
    - Pfizer Investigational Site
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53215
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Efficacy
6-Minute Walk Test
Standard safety data
BORG Dyspnoea Score
WHO Functional Class
Quality of Life SF-36 and EQ-5D

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A1481142

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.