Official Title: “A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension.”

This is a clinical research study designed to evaluate sildenafil for the treatment of Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with oral sildenafil given in three different doses, compared to placebo (inactive treatment).

Efficacy will be measured by exercise and hemodynamics. Patients who complete this trial may be eligible to take part in an extension study, in which all patients will receive active treatment of sildenafil.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: Sildenafil citrate
  • oral, 80 mg, 3 times a day (tid)
• Drug: Sildenafil citrate
  • oral, 20, 40 mg, 3 times a day (tid)
• Drug: Placebo
  • oral, 3 times a day (tid)
• Drug: Sildenafil citrate
  • oral, 10 mg, 3 times a day (tid)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Sildenafil Low dose
• Experimental: Sildenafil High dose
• Experimental: Sildenafil medium dose
• Placebo Comparator: Placebo

Primary Measures

• The primary outcome measured is the percent change in peak volume of oxygen breathed while exercising on a bicycle, from baseline to Week 16.
  • Time Frame: Week 16
    Safety Issue?: No

Secondary Measures

• Hemodynamic measurements at Baseline and Week 16/EOT.
  • Time Frame: Week 16
    Safety Issue?: No

Inclusion Criteria:

• Children aged from 1 to 17 years old who have symptomatic pulmonary arterial hypertension due to: Primary PH, PAH associated with collagen vascular disease, or with certain congenital heart lesions.
• Children developmentally able to exercise using bicycle exercise test

Exclusion Criteria:

• PH other than PAH
• Significant congenital heart disease
• Chronic lung disease

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  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00159913

Study ID Number: A1481131

ClinicalTrials.gov Identifier: NCT00159913

Health Authority: United States: Food and Drug Administration

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