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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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Conditions

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Pulmonary Arterial Hypertension

Keywords

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sildenafil pulmonary arterial hypertension PAH

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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 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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Moscow Research Institute of Pediatrics and Pediatric Surgery

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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A1481307

Identifier Type: -

Identifier Source: org_study_id