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

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NCT01897740

Last updated on April 10, 2018
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FOR MORE INFORMATION
Study Location
Moscow Research Institute of Pediatrics and Pediatric Surgery
Moscow, , 125412 Russian Federation
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-30 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01897740
Pfizer
Available
Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil

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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
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
 
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 [email protected]
Russian Federation
 
 
NCT01897740
A1481307
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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