| 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 Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131
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| Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH.
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| Not Provided
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| Interventional
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| Phase 3
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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| Pulmonary Arterial Hypertension
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- 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)
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- 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
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- Russell S, Beghetti M, Oudiz R, Balagtas C, Zhang M, Ivy D. Effects of oral sildenafil on exercise capacity in children with pulmonary arterial hypertension: a randomised trial. Open Heart. 2019 Dec 3;6(2):e001149. doi: 10.1136/openhrt-2019-001149. eCollection 2019.
- Chanu P, Gao X, Bruno R, Claret L, Harnisch L. A modeling and simulation-based assessment of the impact of confounding factors on the readout of a sildenafil survival trial in pulmonary arterial hypertension. J Pharmacokinet Pharmacodyn. 2019 Oct;46(5):499-509. doi: 10.1007/s10928-019-09654-3. Epub 2019 Sep 20.
- 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.
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| Completed
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| 234
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| 204
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| December 2012
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| December 2012 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
- Patients must complete the 16 Week double-blind efficacy study A1481131.
Exclusion Criteria:
- Any patient who did not complete Study A1481131.
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| Sexes Eligible for Study: |
All |
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| 1 Year to 17 Years (Child)
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| No
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Contact information is only displayed when the study is recruiting subjects
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| Brazil, Chile, Colombia, Guatemala, Hungary, India, Italy, Japan, Malaysia, Mexico, Poland, Russian Federation, Sweden, Taiwan, United States
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| Canada, Costa Rica, Panama, Singapore
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| NCT00159874
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| A1481156
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| Yes
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| Not Provided
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| Not Provided
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| Pfizer
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| July 2014
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