Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil
NCT01897740
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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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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:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2020 |