This is a clinical research study designed to evaluate sildenafil for the treatment of Pulmonary Arterial Hypertension in children, aged 1 to 16 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.

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: Sildenafil citrate	Phase II Phase III

Further Study Details: 

Primary Outcomes: The primary outcome measured is the percent change in peak volume of oxygen breathed while exercising on a bicycle, from baseline to Week 16.; Secondary outcomes include changes in other parameters measured while exercising
Secondary Outcomes: Hemodynamic measurements,; Quality of life,; Safety
Expected Total Enrollment:  204

Ages Eligible for Study:  1 Year   -   16 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Children aged from 1 to 16 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00159913

Pfizer CT.gov Call Center      1-800-718-1021 

California
      Pfizer Investigational Site, Palo Alto,  California,  34304,  United States; Recruiting
      Pfizer Investigational Site, Palo Alto,  California,  94304,  United States; Recruiting
      Pfizer Investigational Site, Stanford,  California,  94305,  United States; Recruiting
Colorado
      Pfizer Investigational Site, Denver,  Colorado,  80218,  United States; Recruiting
Massachusetts
      Pfizer Investigational Site, Boston,  Massachusetts,  02115,  United States; Recruiting
Michigan
      Pfizer Investigational Site, Ann Arbor,  Michigan,  48109,  United States; Recruiting
Missouri
      Pfizer Investigational Site, St. Louis,  Missouri,  63110,  United States; Recruiting
New York
      Pfizer Investigational Site, New York,  New York,  10032,  United States; Recruiting
Ohio
      Pfizer Investigational Site, Columbus,  Ohio,  43205,  United States; Recruiting
South Carolina
      Pfizer Investigational Site, Charleston,  South Carolina,  29425,  United States; Recruiting
Washington
      Pfizer Investigational Site, Seattle,  Washington,  98105,  United States; Recruiting
Wisconsin
      Pfizer Investigational Site, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
Australia, Victoria
      Pfizer Investigational Site, Parkville,  Victoria,  3052,  Australia; No longer recruiting
Canada, Alberta
      Pfizer Investigational Site, Edmonton,  Alberta,  T6G 2B7,  Canada; Recruiting
Canada, British Columbia
      Pfizer Investigational Site, Vancouver,  British Columbia,  V6H 3V4,  Canada; Recruiting
Hungary
      Pfizer Investigational Site, Szeged,  6720,  Hungary; Recruiting
      Pfizer Investigational Site, Budapest,  1096,  Hungary; Recruiting
India, Hyderabad
      Pfizer Investigational Site, Namapally,  Hyderabad,  500 001,  India; Recruiting
India, Kochi,
      Pfizer Investigational Site, Kerala,  Kochi,,  682 026,  India; Recruiting
Italy
      Pfizer Investigational Site, Bologna,  40138,  Italy; Recruiting
Malaysia
      Pfizer Investigational Site, Penang,  10050,  Malaysia; Recruiting
Mexico, Mexico D.F.
      Pfizer Investigational Site, Del. Tlalpan,  Mexico D.F.,  14080,  Mexico; Recruiting
Mexico, Mexico DF
      Pfizer Investigational Site, Tlalpan,  Mexico DF,  14080,  Mexico; Recruiting
Poland
      Pfizer Investigational Site, Warszawa,  04-628,  Poland; Recruiting
      Pfizer Investigational Site, Warszawa,  04-730,  Poland; Recruiting
      Pfizer Investigational Site, Zabrze,  41-800,  Poland; Recruiting
      Pfizer Investigational Site, Krakow,  30-663,  Poland; Recruiting
      Pfizer Investigational Site, Krakow,  31-202,  Poland; Recruiting
Russian Federation
      Pfizer Investigational Site, Moscow,  127412,  Russian Federation; Recruiting
      Pfizer Investigational Site, Moscow,  121552,  Russian Federation; No longer recruiting
Singapore
      Pfizer Investigational Site, Singapore,  229899,  Singapore; Recruiting
Sweden
      Pfizer Investigational Site, Lund,  221 85,  Sweden; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A1481131
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00159913
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13