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Long Term Extension Study Evaluating Safety of Sildenafil Citrate When Used to Treat PAH in Children - Article


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Clinical Trial: Long Term Extension Study Evaluating Safety of Sildenafil Citrate When Used to Treat PAH in Children

This study is currently recruiting patients.
Verified by Pfizer September 2005

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00159874

Purpose

Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH
Condition Intervention Phase
Pulmonary Hypertension
  Drug: Sildenafil citrate
 Phase III

MedlinePlus related topics:  Pulmonary Hypertension

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

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

Further Study Details: 
Primary Outcomes: Standard safety, Ocular safety, Tolerability, Growth and development
Secondary Outcomes: 1-year efficacy, tested with bicycle exercise tolerance test, which measures peak VO2 and gas exchange.
Expected Total Enrollment:  204

Study start: January 2004

Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Any patient who did not complete Study A1481131

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00159874

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,  94305,  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

Washington
      Pfizer Investigational Site, Seattle,  Washington,  98105,  United States; Recruiting

Hungary
      Pfizer Investigational Site, Budapest,  1096,  Hungary; Recruiting

      Pfizer Investigational Site, Szeged,  6720,  Hungary; Recruiting

India, Andhra Pradesh
      Pfizer Investigational Site, Hyderabad,  Andhra Pradesh,  500 001,  India; Recruiting

India, Kerala
      Pfizer Investigational Site, Kochi,  Kerala,  682 026,  India; Recruiting

Italy
      Pfizer Investigational Site, Bologna,  40138,  Italy; Recruiting

Malaysia
      Pfizer Investigational Site, Penang,  10050,  Malaysia; Recruiting

Mexico, DF
      Pfizer Investigational Site, Mexico,  DF,  14080,  Mexico; Recruiting

Mexico, Mexico D.F.
      Pfizer Investigational Site, Del. Tlalpan,  Mexico D.F.,  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

Sweden
      Pfizer Investigational Site, Lund,  221 85,  Sweden; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

More Information

Study ID Numbers:  A1481156
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00159874
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005

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Page Updated: June 1, 2005
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