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

September 8, 2005
January 28, 2013
January 2004
December 2012   (final data collection date for primary outcome measure)
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 ]
Standard safety, Ocular safety, Tolerability, Growth and development
Complete list of historical versions of study NCT00159874 on ClinicalTrials.gov Archive Site
Assess 1 year efficacy data [ Time Frame: > 1 year ] [ Designated as safety issue: No ]
1-year efficacy, tested with bicycle exercise tolerance test, which measures peak VO2 and gas exchange.
Not Provided
Not Provided
 
A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • 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)
  • 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.
    Intervention: Drug: Sildenafil citrate
  • Experimental: Sildenafil Low dose
    Intervention: Drug: Sildenafil citrate
  • 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.
    Intervention: Drug: Sildenafil citrate
Barst RJ, Beghetti M, Pulido T, Layton G, Konourina I, Zhang M, Ivy DD; STARTS-2 Investigators. STARTS-2: long-term survival with oral Sildenafil monotherapy in treatment-naive pediatric pulmonary arterial hypertension. Circulation. 2014 May 13;129(19):1914-23. doi: 10.1161/CIRCULATIONAHA.113.005698. Epub 2014 Mar 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
221
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Any patient who did not complete Study A1481131.
Both
1 Year to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Chile,   Colombia,   Guatemala,   Hungary,   India,   Italy,   Japan,   Malaysia,   Mexico,   Poland,   Russian Federation,   Sweden,   Taiwan
 
NCT00159874
A1481156
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP