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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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8 February 2021 |
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Main ID: |
NCT00159887 |
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Date of registration:
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08/09/2005 |
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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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Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension
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Scientific title:
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A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140. |
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Date of first enrolment:
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December 2002 |
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Target sample size:
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260 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00159887 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Belgium
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Brazil
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Czech Republic
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Czechia
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Denmark
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France
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Germany
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Hong Kong
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Hungary
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Israel
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Italy
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Korea, Republic of
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Malaysia
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Mexico
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Netherlands
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Poland
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Singapore
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South Africa
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Spain
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Sweden
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United Kingdom
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United States
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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 with PAH who had completed the 12 week pivotal study
Exclusion Criteria:
- Any other patients with PAH that had not been included into the pivotal study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Hypertension
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Intervention(s)
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Drug: Sildenafil citrate
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Primary Outcome(s)
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Standard safety data
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Quality of Life SF-36 and EQ-5D
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6-Minute Walk Test
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WHO Functional Class
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BORG Dyspnoea Score
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Efficacy
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Safety
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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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