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An Open Label Access Study For Subjects Who Completed A1481156

Primary Purpose

Pulmonary Arterial Hypertension

Status
No longer available
Phase
Locations
India
Study Type
Expanded Access
Intervention
Access program - sildenafil citrate, Viagra, Revatio
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 expanded access trial for Pulmonary Arterial Hypertension

Eligibility Criteria

12 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who have completed study A1481156 and are judged by the Investigator to derive clinical benefit from continuous treatment with sildenafil citrate therapy.
  • Subjects with pulmonary arterial hypertension (PAH ) being treated at a study site in India
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures

Exclusion Criteria:

  • Pregnant or lactating female subjects.
  • Current participation in other studies and during study participation, except for the A1481304 follow-up period.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Sites / Locations

  • CARE Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 19, 2012
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
NCT01582438
Brief Title
An Open Label Access Study For Subjects Who Completed A1481156
Official Title
A Local, Multicentre, Open Label Access Study, To Provide Sildenafil Therapy For Subjects Who Completed A1481156 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil For Subjects In India
Study Type
Expanded Access

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

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
The purpose of this study is to provide sildenafil therapy to subjects who have completed the A1481156 study for the treatment of Pulmonary Arterial Hypertension (PAH) in India and are judged by the Investigator to derive clinical benefit from continued treatment with sildenafil citrate. Sildenafil citrate will be supplied for the treatment of Pulmonary Arterial Hypertension (PAH) until the subject continues to derive benefits from the treatment. The treating physicians (and the sponsor) will be responsible for reporting serious adverse events.

6. Conditions and Keywords

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

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Access program - sildenafil citrate, Viagra, Revatio
Other Intervention Name(s)
sildenafil citrate, Viagra, Revatio
Intervention Description
The recommended dose is 20 mg TID for subjects with body weight > 20 kg and 10 mg TID for subjects with body weight ≤ 20 kg. If subject is 18 years of age or older, the recommended dose is 20 mg TID, regardless of body weight. If a subject was receiving a higher dose in study A1481156 and the investigator believes that the subject requires continued treatment on that dose, or if dose reduction is judged to be associated with pulmonary arterial hypertension (PAH) deterioration in a particular subject, the higher dose may be made available, as judged on an individual basis on discussion with the sponsor.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who have completed study A1481156 and are judged by the Investigator to derive clinical benefit from continuous treatment with sildenafil citrate therapy. Subjects with pulmonary arterial hypertension (PAH ) being treated at a study site in India Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures Exclusion Criteria: Pregnant or lactating female subjects. Current participation in other studies and during study participation, except for the A1481304 follow-up period. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration and, in the judgment of the investigator, would make the subject inappropriate for entry into this 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
CARE Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 001
Country
India

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481304&StudyName=An%20Open%20Label%20Access%20Study%20For%20Subjects%20Who%20Completed%20A1481156
Description
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An Open Label Access Study For Subjects Who Completed A1481156

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