Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• 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)
• 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: 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)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Sildenafil high dose
• Experimental: Sildenafil Low dose
• Experimental: Sildenafil medium dose

Primary Measures

• Standard Safety tests. Ocular safety measures at Week 36, need for down-titration or discontinuation due to intolerability
  • Time Frame: >1 year
    Safety Issue?: Yes

Secondary Measures

• Assess 1 year efficacy data
  • Time Frame: > 1 year
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

• Any patient who did not complete Study A1481131.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Year

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00159874

Study ID Number: A1481156

ClinicalTrials.gov Identifier: NCT00159874

Health Authority: United States: Food and Drug Administration

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