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

Verified by: Pfizer, January 2012
First Received: September 8, 2005 | Last Updated: January 18, 2012 | Phase: Phase 3 | Start Date: January 2004
Overall Status: Active, not recruiting | Estimated Enrollment: 204
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Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: April 2012

Intervention(s) in this Clinical Trial

  • 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)

Arms, Groups and Cohorts in this Clinical Trial

  • 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.
  • Experimental: Sildenafil Low dose
  • 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.

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

To obtain contact information for a study center near you, click here.

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