Back to resultsSildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil
Primary Purpose
Pulmonary Arterial Hypertension
Status
No longer available
Phase
Locations
Russian Federation
Study Type
Expanded Access
Intervention
sildenafil
Sponsored by
About this trial
This is an expanded access trial for Pulmonary Arterial Hypertension focused on measuring sildenafil, pulmonary arterial hypertension, PAH
Eligibility Criteria
Inclusion Criteria:
- Patients Who Completed study A1481156 and Are Judged by the Investigator to Derive Clinical Benefit from Continued Treatment with Sildenafil, Prior to Reimbursement and Availability for Subjects in Russian Federation.
- Child bearing age women should have appropriate contraception.
- Signed informed consent. Patients who have a wish and possibility to follow treatment regimens in terms of the study.
Exclusion Criteria:
- Pregnant and lactating women.
- Participation in other studies in the current moment or during study period except of A1481156.
- Patients with severe acute or chronic diseases psychiatric disorders or laboratory abnormalities.
Sites / Locations
- Moscow Research Institute of Pediatrics and Pediatric Surgery
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01897740
First Posted
July 8, 2013
Last Updated
December 19, 2020
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01897740
Brief Title
Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil
Official Title
A LOCAL, SINGLE-CENTRE, EXTENSION, 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, PRIOR TO REIMBURSEMENT AND AVAILABILITY FOR SUBJECTS IN RUSSIAN FEDERATION
Study Type
Expanded Access
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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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 for subjects who completed A1481156 study and are judged by the investigator to derive clinical benefit from continued treatment with Sildenafil, prior to reimbursement and availability for subjects in the Russian Federation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
sildenafil, pulmonary arterial hypertension, PAH
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sildenafil
Intervention Description
tablets of sildenafil 20 mg 3 times a day 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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients Who Completed study A1481156 and Are Judged by the Investigator to Derive Clinical Benefit from Continued Treatment with Sildenafil, Prior to Reimbursement and Availability for Subjects in Russian Federation.
Child bearing age women should have appropriate contraception.
Signed informed consent. Patients who have a wish and possibility to follow treatment regimens in terms of the study.
Exclusion Criteria:
Pregnant and lactating women.
Participation in other studies in the current moment or during study period except of A1481156.
Patients with severe acute or chronic diseases psychiatric disorders or laboratory abnormalities.
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
Moscow Research Institute of Pediatrics and Pediatric Surgery
City
Moscow
ZIP/Postal Code
125412
Country
Russian Federation
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481307&StudyName=Sildenafil%20Therapy%20For%20Subjects%20Who%20Derive%20Clinical%20Benefit%20from%20Continued%20Treatment%20With%20Sildenafil
Description
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Learn more about this trial
Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil
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