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

Expanded access is currently available for this treatment.
Verified September 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01897740
First received: July 8, 2013
Last updated: September 13, 2016
Last verified: September 2016

July 8, 2013
September 13, 2016
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Complete list of historical versions of study NCT01897740 on ClinicalTrials.gov Archive Site
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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.
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Expanded Access
Phase 4
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Pulmonary Arterial Hypertension (PAH)
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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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 apropriate 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.
Both
10 Years to 30 Years   (Child, Adult)
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Russian Federation
 
NCT01897740
A1481307
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Pfizer
Pfizer
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Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP