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

Expanded access is currently available for this treatment.
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01897740
First received: July 8, 2013
Last updated: August 11, 2014
Last verified: August 2014

July 8, 2013
August 11, 2014
July 2012
July 2014   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01897740 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Not Provided
Expanded Access
Phase 4
Not Provided
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available
Not Provided
August 2014
July 2014   (final data collection date for primary outcome measure)

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
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Russian Federation
 
NCT01897740
A1481307
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

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