A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children
NCT ID: NCT00159874
Last Updated: 2021-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
234 participants
INTERVENTIONAL
2004-01-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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)
Sildenafil Low dose
Sildenafil citrate
Oral,10 mg 3 times a day (tid), only subjects with body weight \>20 kg
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.
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)
Interventions
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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)
Sildenafil citrate
Oral,10 mg 3 times a day (tid), only subjects with body weight \>20 kg
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 Criteria
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Inclusion Criteria
Exclusion Criteria
1 Year
17 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
Stanford, California, United States
Pfizer Investigational Site
Aurora, Colorado, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Ann Arbor, Michigan, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Columbus, Ohio, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
Puente Alto, Santiago Metropolitan, Chile
Pfizer Investigational Site
Medellín, Antioquia, Colombia
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Pfizer Investigational Site
Guatemala City, , Guatemala
Pfizer Investigational Site
Budapest, , Hungary
Pfizer Investigational Site
Budapest, , Hungary
Pfizer Investigational Site
Szeged, , Hungary
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India
Pfizer Investigational Site
Kochi, Kerala, India
Pfizer Investigational Site
Bologna, , Italy
Pfizer Investigational Site
Tokyo, , Japan
Pfizer Investigational Site
George Town, Pulau Pinang, Malaysia
Pfizer Investigational Site
George Town, Pulau Pinang, Malaysia
Pfizer Investigational Site
George Town, Pulau Pinang, Malaysia
Pfizer Investigational Site
Mexico City, Mexico City, Mexico
Pfizer Investigational Site
Krakow, , Poland
Pfizer Investigational Site
Ruda Śląska, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Zabrze, , Poland
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Lund, , Sweden
Pfizer Investigational Site
Kaohsiung City, , Taiwan
Pfizer Investigational Site
Taipei, , Taiwan
Pfizer Investigational Site
Taipei, , Taiwan
Countries
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References
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Russell S, Beghetti M, Oudiz R, Balagtas C, Zhang M, Ivy D. Effects of oral sildenafil on exercise capacity in children with pulmonary arterial hypertension: a randomised trial. Open Heart. 2019 Dec 3;6(2):e001149. doi: 10.1136/openhrt-2019-001149. eCollection 2019.
Chanu P, Gao X, Bruno R, Claret L, Harnisch L. A modeling and simulation-based assessment of the impact of confounding factors on the readout of a sildenafil survival trial in pulmonary arterial hypertension. J Pharmacokinet Pharmacodyn. 2019 Oct;46(5):499-509. doi: 10.1007/s10928-019-09654-3. Epub 2019 Sep 20.
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.
Related Links
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Other Identifiers
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A1481156
Identifier Type: -
Identifier Source: org_study_id
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