Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

October 6, 2014

Primary Completion Date

February 21, 2018

Study Completion Date

December 4, 2019

Conditions
Cushings Disease
Interventions
DRUG

osilodrostat

Osilodrostat comes in the form of film-coated tablets for oral administration, in the following strengths: 1 mg, 5 mg, 10 mg, and 20 mg. The maximum dose of osilodrostat was 30 mg bid.

DRUG

LCI699 matching placebo

Osilodrostat placebo comes in the form of film-coated tablets for oral administration, in the following strengths: 1 mg, 5 mg, 10 mg, and 20 mg. The maximum dose of osilodrostat placebo was 30 mg bid.

Trial Locations (60)

1090

Novartis Investigative Site, Vienna

1431

Novartis Investigative Site, Sofia

10029

Mount Sinai School of Medicine SC - LCI699C2301, New York

10032

Columbia University Medical Center New York Presbyterian SC - LCI699C2301, New York

10065

Memorial Sloan Kettering Cancer Center, New York

13385

Novartis Investigative Site, Marseille

16132

Novartis Investigative Site, Genova

19104

University of Pennsylvania Clinical Studies Unit Unniv SC, Philadelphia

20122

Novartis Investigative Site, Milan

21205

The Johns Hopkins University School of Medicine Johns Hopkins University, Baltimore

28009

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

30322

Emory University School of Medicine G2304 - C2301, Atlanta

33604

Novartis Investigative Site, Pessac

34098

Novartis Investigative Site, Istanbul

35128

Novartis Investigative Site, Padua

41013

Novartis Investigative Site, Seville

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

53226

Medical College of Wisconsin MCW 2, Milwaukee

56124

Novartis Investigative Site, Pisa

59037

Novartis Investigative Site, Lille

60126

Novartis Investigative Site, Ancona

60611

Northwestern University SC - LCI699C2301, Chicago

75014

Novartis Investigative Site, Paris

80045

University of Colorado Hospital SC - LCI699C2301, Aurora

80131

Novartis Investigative Site, Napoli

81377

Novartis Investigative Site, München

90110

Novartis Investigative Site, Songkhla

91054

Novartis Investigative Site, Erlangen

94275

Novartis Investigative Site, Le Kremlin-Bicêtre

97239

Oregon Health and Science University SC LCI699C2301, Portland

98125

Novartis Investigative Site, Messina

100034

Novartis Investigative Site, Beijing

100730

Novartis Investigative Site, Beijing

110029

Novartis Investigative Site, New Delhi

117036

Novartis Investigative Site, Moscow

160012

Novartis Investigative Site, Chandigarh

560054

Novartis Investigative Site, Bangalore

610041

Novartis Investigative Site, Chengdu

632004

Novartis Investigative Site, Vellore

02114

Massachusetts General Hospital Neuroendocrine Unit, Boston

C1180AAX

Novartis Investigative Site, CABA

C1426AAI

Novartis Investigative Site, CABA

T6G 2B7

Novartis Investigative Site, Edmonton

B3H 1V7

Novartis Investigative Site, Halifax

H2W 1T8

Novartis Investigative Site, Montreal

J1H 5N4

Novartis Investigative Site, Sherbrooke

Unknown

Novartis Investigative Site, Santiago de Cali

460-0001

Novartis Investigative Site, Nagoya

812-8582

Novartis Investigative Site, Fukuoka

650-0017

Novartis Investigative Site, Kobe

663 8501

Novartis Investigative Site, Nishinomiya

245-8575

Novartis Investigative Site, Yokohama

113-8603

Novartis Investigative Site, Bunkyo-ku

160-0023

Novartis Investigative Site, Shinjuku-ku

3015 GD

Novartis Investigative Site, Rotterdam

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

S10 2JF

Novartis Investigative Site, Sheffield

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY