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

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NCT01897740

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Study Location
Moscow Research Institute of Pediatrics and Pediatric Surgery
Moscow, , 125412, Russian Federation
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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.

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Advanced Information
Descriptive Information
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
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.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition Pulmonary Arterial Hypertension
Intervention 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
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.
Sex/Gender
Sexes Eligible for Study:All
Ages 10 Years to 30 Years   (Child, Adult)
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT01897740
Other Study ID Numbers A1481307
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2020