A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children
NCT00159874
Last updated date
ABOUT THIS STUDY
Active treatment, dose-blinded extension study evaluating the safety and long term efficacy
of sildenafil citrate in children with PAH.
Study Location
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
Eligibility Criteria
condition
Pulmonary Arterial Hypertension
Sex
Females and Males
Age
1-17 year
Inclusion Criteria
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- Patients must complete the 16 Week double-blind efficacy study A1481131.
Exclusion Criteria
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- Any patient who did not complete Study A1481131.
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children | |||
Official Title ICMJE | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131 | |||
Brief Summary | Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Pulmonary Arterial Hypertension | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 234 | |||
Original Enrollment ICMJE | 204 | |||
Actual Study Completion Date ICMJE | December 2012 | |||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 1 Year to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Brazil, Chile, Colombia, Guatemala, Hungary, India, Italy, Japan, Malaysia, Mexico, Poland, Russian Federation, Sweden, Taiwan, United States | |||
Removed Location Countries | Canada, Costa Rica, Panama, Singapore | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00159874 | |||
Other Study ID Numbers ICMJE | A1481156 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |