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Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study (UK 92480)

Primary Purpose

Pulmonary Arterial Hypertension

Status
No longer available
Phase
Locations
India
Study Type
Expanded Access
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 expanded access trial for Pulmonary Arterial Hypertension focused on measuring Open label access, sildenafil, pulmonary arterial hypertension

Eligibility Criteria

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

Inclusion Criteria:

  • Subject who complete the A1481244 study and require Sildenafil (Revatio TM) 20 mg TID therapy.
  • All women of childbearing potential must use adequate contraception throughout the study and four weeks after completion of the study

Exclusion Criteria:

  • Pregnant or lactating women
  • Participation in other studies during study participation
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

Sites / Locations

  • The Institute of Medical Sciences, CARE Hospital
  • Mehta Hospital & Cardiopulmonary Care Center
  • Bankers Heart Institute
  • St Johns Medical College Hospital
  • Metro Multispeciality Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 8, 2009
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
NCT00878943
Brief Title
Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study
Acronym
UK 92480
Official Title
A Local, Multi-centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study In India Or Ongoing In A1481269 Study Who Continue To Receive Benefit From Sildenafil Therapy.
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
In an earlier study, sildenafil citrate administered to patients of PAH led to improvement in pulmonary arterial pressure, cardiac output, quality of life, and other parameters as compared to placebo. This protocol provides mechanism for patients who have clinical deterioration on other PAH approved therapies to have access to sildenafil prior to marketing authorization in India.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Open label access, sildenafil, pulmonary arterial hypertension

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sildenafil citrate
Intervention Description
20 mg tablet to be taken thrice daily for 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject who complete the A1481244 study and require Sildenafil (Revatio TM) 20 mg TID therapy. All women of childbearing potential must use adequate contraception throughout the study and four weeks after completion of the study Exclusion Criteria: Pregnant or lactating women Participation in other studies during study participation Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
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
The Institute of Medical Sciences, CARE Hospital
City
Hyderabad
State/Province
Andra Pradesh
ZIP/Postal Code
500 001
Country
India
Facility Name
Mehta Hospital & Cardiopulmonary Care Center
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 054
Country
India
Facility Name
Bankers Heart Institute
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390 015
Country
India
Facility Name
St Johns Medical College Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 034
Country
India
Facility Name
Metro Multispeciality Hospital
City
Noida
State/Province
Uttar Pradesh
ZIP/Postal Code
201301
Country
India

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481269&StudyName=Open%20Label%20Access%20Study%20Of%20Sildenafil%20In%20Adult%20Patients%20With%20Pulmonary%20Arterial%20Hypertension%20Completing%20A1481244%20Study
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study

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