A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)

PHASE3CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

February 5, 2014

Primary Completion Date

March 18, 2019

Study Completion Date

March 10, 2021

Conditions
Hypertension, Pulmonary
Interventions
DRUG

Tadalafil

Administered orally by tablet form for heavy and middle weight participants. Administered orally by suspension for light weight participants.

DRUG

Placebo

Administered orally by tablet for heavy and middle weight participants. Administered orally by suspension for light weight participants.

DRUG

ERA as specific PAH treatment

All participants were taking endothelin receptor antagonist (ERA) (such as bosentan, ambrisentan and macitentan).

Trial Locations (43)

1090

AKH, Vienna

3000

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven

13385

CHU Hopital d'enfants de la Timone, Marseille

14080

Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City

16147

Istituto Giannina Gaslini Ospedale Pediatrico I.R.C.C.S., Genova

28034

Hospital Universitario Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

30322

Children's Heathcare of Atlanta, Inc. at Egleston, Atlanta

31026

Chu de Toulouse - Hopital des Enfants, Toulouse

33604

Hopital Haut Leveque - Group hospitalier Sud, Pessac

45229

Cincinnati Childrens Hospital Medical Center, Cincinnati

48201

Childrens Hospital of Michigan, Detroit

69120

Universitätsklinikum Heidelberg, Heidelberg

75743

GH Necker - Enfants Malades, Paris

77030

Texas Childrens Hospital, Houston

80131

Ospedale V. Monaldi, Napoli

84132

Primary Childrens Medical Center, Salt Lake City

89075

Universitätsklinikum Ulm, Ulm

4920235

Schneider Medical Center, Petah Tikva

5265601

Sheba Medical Center, Tel Litwinsky

43205-2664

Nationwide Children's Hosp, Columbus

37212-2372

Vanderbilt Univeristy School of Medicine, Nashville

50100-060

Pronto Socorro Cardiologico de Pernambuco-PROCAPE, Recife

90020-090

Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre

04012-180

Instituto Dante Pazzanese de Cardiologia, São Paulo

04037-002

UNIFESP - Escola Paulista de Medicina, São Paulo

00165

Ospedale Bambino Gesu, Roma

377-8577

Gunma Children's Medical Center, Shibukawa

078-8510

Asahikawa Medical College Hospital, Asahikawa

514-8507

Mie University Hospital, Tsu

901-1193

Okinawa Prefectural Nanbu Medical Center & Children's Med Ct, Haebaru-cho, Shimajiri-gun

183-8561

Tokyo Metropolitan Children's Medical Center, Fuchū

143-8541

Toho University Omori Medical Center, Ohta-Ku

157-8535

National Center For Child Health And Development, Setagaya-ku

420-8660

Shizuoka Prefectural Children's Hospital, Shizuoka

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

04-730

Instytut Pomnik-Centrum Zdrowia Dziecka, Warsaw

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

30-633

Uniwersytecki Szpital Dzieciecy w Krakowie-Prokocimiu, Krakow

51-124

Wojewódzki Szpital Specjalistyczny we Wrocławiu, Wroclaw

08035

Hospital Universitari Vall d'Hebron, Barcelona

06100

Hacettepe University Faculty of Medicine, Ankara

06500

Gazi University Medical Faculty, Besevler/Ankara

All Listed Sponsors
lead

Eli Lilly and Company

INDUSTRY

NCT01824290 - A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH) | Biotech Hunter | Biotech Hunter