NCT01642407View on ClinicalTrials.gov

Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension

PHASE4CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

August 24, 2012

Primary Completion Date

May 20, 2016

Study Completion Date

March 12, 2018

Conditions
Pulmonary Arterial HypertensionHypertension, Pulmonary
Interventions
DRUG

Sildenafil

Body weight \> 20 kg: 20 mg TID (60 mg/day) Body weight ≤ 20 kg: 10 mg TID (30 mg/day) Treatment duration: 16 weeks in Part 1, until until sildenafil obtained marketing approval in Part 2

Trial Locations (5)

252-0375

Kitasato University Hospital, Sagamihara

565-0871

Osaka University Hospital, Suita

143-8541

Toho University Omori Medical Center, Ōta-ku

157-8535

National Center for Child Health and Development, Setagaya-ku

420-8660

Shizuoka Children's Hospital, Shizuoka

All Listed Sponsors
lead

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

INDUSTRY

NCT01642407 - Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension | Biotech Hunter | Biotech Hunter