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

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sildenafil citrate
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00159887
Brief Title
Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sildenafil citrate
Primary Outcome Measure Information:
Title
Safety
Title
Standard safety data
Title
Efficacy
Title
6-Minute Walk Test
Title
BORG Dyspnoea Score
Title
WHO Functional Class
Title
Quality of Life SF-36 and EQ-5D

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0006
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8320
Country
United States
Facility Name
Pfizer Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5735
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Pfizer Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Pfizer Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Prague 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Prague 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Kobenhavn
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Clamart Cedex
ZIP/Postal Code
92141
Country
France
Facility Name
Pfizer Investigational Site
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Pfizer Investigational Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Pfizer Investigational Site
City
Shatin NT
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Pfizer Investigational Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Petaling Jaya
ZIP/Postal Code
46200
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Tlalpan Mexico
State/Province
DF
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Tlalpan
State/Province
Mexico DF
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Pfizer Investigational Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
168752
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Parow
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Parktown West
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Papworth Everard
State/Province
Cambridgeshire
ZIP/Postal Code
CB3 8RE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Cambridge
ZIP/Postal Code
CB4 9EL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22354598
Citation
Wirostko BM, Tressler C, Hwang LJ, Burgess G, Laties AM. Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension. BMJ. 2012 Feb 21;344:e554. doi: 10.1136/bmj.e554.
Results Reference
derived
PubMed Identifier
21546436
Citation
Rubin LJ, Badesch DB, Fleming TR, Galie N, Simonneau G, Ghofrani HA, Oakes M, Layton G, Serdarevic-Pehar M, McLaughlin VV, Barst RJ; SUPER-2 Study Group. Long-term treatment with sildenafil citrate in pulmonary arterial hypertension: the SUPER-2 study. Chest. 2011 Nov;140(5):1274-1283. doi: 10.1378/chest.10-0969. Epub 2011 May 5.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481142&StudyName=Study%20to%20Assess%20%20the%20Longterm%20Safety%20of%20Sildenafil%20Citrate%20in%20Patients%20with%20Pulmonary%20Arterial%20Hypertension
Description
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Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension

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