NCT00159874 - A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children | Biotech Hunter

Enrollment

234

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions

Pulmonary Arterial Hypertension

Interventions

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)

Trial Locations (39)

100

Pfizer Investigational Site, Taipei

1083

Pfizer Investigational Site, Budapest

1096

Pfizer Investigational Site, Budapest

6720

Pfizer Investigational Site, Szeged

10032

Pfizer Investigational Site, New York

10050

Pfizer Investigational Site, George Town

10900

Pfizer Investigational Site, George Town

11217

Pfizer Investigational Site, Taipei

11600

Pfizer Investigational Site, George Town

14080

Pfizer Investigational Site, Mexico City

29425

Pfizer Investigational Site, Charleston

34304

Pfizer Investigational Site, Palo Alto

40138

Pfizer Investigational Site, Bologna

43205

Pfizer Investigational Site, Columbus

48109

Pfizer Investigational Site, Ann Arbor

63110

Pfizer Investigational Site, St Louis

80045

Pfizer Investigational Site, Aurora

81346

Pfizer Investigational Site, Kaohsiung City

94305

Pfizer Investigational Site, Palo Alto

Pfizer Investigational Site, Stanford

98105

Pfizer Investigational Site, Seattle

115478

Pfizer Investigational Site, Moscow

125412

Pfizer Investigational Site, Moscow

02115

Pfizer Investigational Site, Boston

04012-909

Pfizer Investigational Site, São Paulo

04023-062

Pfizer Investigational Site, São Paulo

Unknown

Pfizer Investigational Site, Puente Alto

Pfizer Investigational Site, Medellín

Pfizer Investigational Site, Bogota

Pfizer Investigational Site, Guatemala City

Pfizer Investigational Site, Tokyo

500 001

Pfizer Investigational Site, Hyderabad

500 073

Pfizer Investigational Site, Hyderabad

682 041

Pfizer Investigational Site, Kochi

30-663

Pfizer Investigational Site, Krakow

41-703

Pfizer Investigational Site, Ruda Śląska

04-730

Pfizer Investigational Site, Warsaw

41-800

Pfizer Investigational Site, Zabrze

221 85

Pfizer Investigational Site, Lund

All Listed Sponsors

lead

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY