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Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil

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ClinicalTrials.gov Identifier: NCT01897740
Recruitment Status : Available
First Posted : July 12, 2013
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

July 8, 2013
July 12, 2013
January 31, 2018
 
Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil
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
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.
Not Provided
Expanded Access
Individual Patients
Pulmonary Arterial Hypertension
Drug: sildenafil
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available

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.
Sexes Eligible for Study: All
10 Years to 30 Years   (Child, Adult)
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Russian Federation
 
 
NCT01897740
A1481307
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2018