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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00159874
First received: September 8, 2005
Last updated: January 28, 2013
Last verified: January 2013
  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 Arterial Hypertension
Drug: Sildenafil citrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Standard Safety tests. Ocular safety measures at Week 36, need for down-titration or discontinuation due to intolerability [ Time Frame: >1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess 1 year efficacy data [ Time Frame: > 1 year ] [ Designated as safety issue: No ]

Enrollment: 221
Study Start Date: January 2004
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)
Experimental: Sildenafil Low dose Drug: Sildenafil citrate
Oral,10 mg 3 times a day (tid), only subjects with body weight >20 kg
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.
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)

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any patient who did not complete Study A1481131.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159874

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Palo Alto, California, United States, 34304
Pfizer Investigational Site
Palo Alto, California, United States, 94305
Pfizer Investigational Site
Stanford, California, United States, 94305
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10032
United States, Ohio
Pfizer Investigational Site
Columbus, Ohio, United States, 43205
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98105
Brazil
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04012-909
Pfizer Investigational Site
São Paulo, SP, Brazil, 04023-062
Chile
Pfizer Investigational Site
Puente Alto, Santiago, Chile
Colombia
Pfizer Investigational Site
Medellin, Antioquia, Colombia
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Guatemala
Pfizer Investigational Site
Guatemala, Guatemala
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1083
Pfizer Investigational Site
Budapest, Hungary, 1096
Pfizer Investigational Site
Szeged, Hungary, 6720
India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 001
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 073
Pfizer Investigational Site
Kochi, Kerala, India, 682 041
Italy
Pfizer Investigational Site
Bologna, Italy, 40138
Japan
Pfizer Investigational Site
Tokyo, Japan
Malaysia
Pfizer Investigational Site
Penang, Malaysia, 10900
Pfizer Investigational Site
Penang, Malaysia, 10050
Pfizer Investigational Site
Penang, Malaysia, 11600
Mexico
Pfizer Investigational Site
Mexico, DF, Mexico, 14080
Poland
Pfizer Investigational Site
Krakow, Poland, 30-663
Pfizer Investigational Site
Ruda Slaska, Poland, 41-703
Pfizer Investigational Site
Warszawa, Poland, 04-730
Pfizer Investigational Site
Zabrze, Poland, 41-800
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 115478
Pfizer Investigational Site
Moscow, Russian Federation, 125412
Sweden
Pfizer Investigational Site
Lund, Sweden, 221 85
Taiwan
Pfizer Investigational Site
Kaohsiung, Taiwan, 81346
Pfizer Investigational Site
Taipei, Taiwan, 100
Pfizer Investigational Site
Taipei, Taiwan, 11217
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00159874     History of Changes
Other Study ID Numbers: A1481156
Study First Received: September 8, 2005
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
children

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Citric Acid
Sildenafil
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014