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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01897740 |
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Date of registration:
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08/07/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil
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Scientific title:
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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 |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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Recruitment status: |
No longer available |
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URL:
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https://clinicaltrials.gov/show/NCT01897740 |
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Study type:
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Expanded Access |
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Study design:
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Phase:
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion 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.
Age minimum:
10 Years
Age maximum:
30 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: sildenafil
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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