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A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children

Last updated on May 12, 2018

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Study Location
Pfizer Investigational Site
Palo Alto, California, 34304 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-17 year
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients must complete the 16 Week double-blind efficacy study A1481131.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any patient who did not complete Study A1481131.

NCT00159874
Pfizer
Completed
A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children

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A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children
A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131
Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: Sildenafil citrate
    Oral, subjects with body weight ?8 - 20 kg: 20 mg 3 times a day (tid) subjects with body weight >20 - 45 kg: 40 mg 3 times a day (tid) subjects with body weight >45 kg: 80 mg 3 times a day (tid)
  • Drug: Sildenafil citrate
    Oral,10 mg 3 times a day (tid), only subjects with body weight >20 kg
  • Drug: Sildenafil citrate
    Oral, subjects with body weight ?8 - 20 kg: 10 mg 3 times a day (tid); subjects with body weight >20 - 45 kg: 20 mg 3 times a day (tid); subjects with body weight >45 kg: 40 mg 3 times a day (tid)
  • Experimental: Sildenafil high dose
    As per Protocol Amendment 8 (Aug 2011), all doses in the high dose treatment group were discontinued. Subjects who were receiving these doses and continued in the study were requested to down titrate.
    Intervention: Drug: Sildenafil citrate
  • Experimental: Sildenafil Low dose
    Intervention: Drug: Sildenafil citrate
  • Experimental: Sildenafil medium dose
    As per Protocol Amendment 8 (August 2011), the dose 40 mg TID in the medium dose treatment group was discontinued. Subjects who were receiving this dose and continued in the study were requested to down titrate.
    Intervention: Drug: Sildenafil citrate
Barst RJ, Beghetti M, Pulido T, Layton G, Konourina I, Zhang M, Ivy DD; STARTS-2 Investigators. STARTS-2: long-term survival with oral sildenafil monotherapy in treatment-naive pediatric pulmonary arterial hypertension. Circulation. 2014 May 13;129(19):1914-23. doi: 10.1161/CIRCULATIONAHA.113.005698. Epub 2014 Mar 17.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
234
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must complete the 16 Week double-blind efficacy study A1481131.

Exclusion Criteria:

  • Any patient who did not complete Study A1481131.
Sexes Eligible for Study: All
1 Year to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Chile,   Colombia,   Guatemala,   Hungary,   India,   Italy,   Japan,   Malaysia,   Mexico,   Poland,   Russian Federation,   Sweden,   Taiwan,   United States
Canada,   Costa Rica,   Panama,   Singapore
 
NCT00159874
A1481156
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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