Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia

PHASE3CompletedINTERVENTIONAL
Enrollment

528

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

October 10, 2019

Study Completion Date

October 10, 2019

Conditions
Schizophrenia
Interventions
DRUG

Lu AF35700

"Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally.~From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day)~Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study"

Trial Locations (102)

10032

US1394, New York

11432

US1244, Fresh Meadows

14618

US1171, Rochester

19403

US1124, Norristown

30328

US1403, Atlanta

30331

US1009, Atlanta

33122

US1130, Miami

33319

US1318, Lauderhill

39232

US1086, Flowood

60640

US1046, Chicago

75243

US1065, Dallas

91945

US1399, Escondido

91950

US1114, National City

92626

US1062, Costa Mesa

92845

US1104, Garden Grove

92868

US1368, Orange

Unknown

US1018, Bellflower

US1463, Culver City

US1459, Oceanside

BG1030, Burgas

BG1028, Kazanlak

BG1003, Lovech

BG1008, Plovdiv

BG1024, Sofia

BG1026, Sofia

BG1034, Varna

BG1029, Veliko Tarnovo

BG1027, Vratsa

CA1029, Penticton

CZ1023, Brno

CZ1032, Brno

CZ1013, Lnáře

CZ1038, Prague

EE1007, Tallinn

MX1024, Durango

MX1011, Guadalajara

MX1021, Guadalajara

MX1022, Guadalajara

MX1020, Mexico City

MX1005, Monterrey

MX1007, Monterrey

MX1015, Monterrey

PL1043, Bialystok

PL1060, Lodz

PL1058, Pruszcz Gdański

PL1059, Torun

PL1051, Wroclaw

RO1024, Bucharest

RU1009, Arkhangelsk

RU1021, Gatchina

RU1006, Moscow

RU1051, Moscow

RU1055, Moscow

RU1053, Roshchino

RU1023, Saint Petersburg

RU1028, Saint Petersburg

RU1030, Saint Petersburg

RU1031, Saint Petersburg

RU1049, Saint Petersburg

RU1052, Saint Petersburg

RU1056, Saint Petersburg

RU1050, Yaroslavl

RS1008, Belgrade

RS1010, Belgrade

RS1012, Belgrade

RS1001, Kovin

RS1011, Kragujevac

RS1016, Kragujevac

RS1017, Kragujevac

RS1009, Novi Kneževac

SK1014, Bratislava

SK1024, Bratislava

SK1026, Zlaté Moravce

ES1047, Barcelona

ES1008, Málaga

ES1048, Oviedo

UA1017, Kharkiv

UA1035, Kharkiv

UA1029, Kherson

UA1027, Kiev

UA1028, Kiev

UA1030, Kiev

UA1031, Kiev

UA1033, Lviv

UA1019, Odesa

UA1020, Odesa

UA1032, Oleksandrivka

UA1001, Poltava

UA1036, Vinnitsa

92408-3332

US1391, San Bernardino

90502-4432

US1392, Torrance

33161-5834

US1129, North Miami

33334-4400

US1402, Oakland Park

60169-1067

US1423, Hoffman Estates

71101-4603

US1398, Shreveport

71104-2136

US1404, Shreveport

89102-1943

US1444, Las Vegas

08009

US1426, Berlin

10035-6000

US1416, New York

10312-6501

US1190, Staten Island

28204-3110

US1390, Charlotte

78754-5122

US1451, Austin

All Listed Sponsors
lead

H. Lundbeck A/S

INDUSTRY

NCT02892422 - Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia | Biotech Hunter | Biotech Hunter