NCT02150213 - Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions

Adrenocortical AdenomaEndometrial Stromal Sarcomas

Interventions

PROCEDURE

MRI, CT or ultrasound was permitted if MRI was contraindicated

MRI/CT/ultrasound of abdomen

PROCEDURE

Dexamethasone Supression Test

Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol

PROCEDURE

Sonogram

Sonogram of the uterus (females only)

PROCEDURE

Biopsy

Uterine endometrial biopsy (females only)

DRUG

BGG492

No study-drug was administered in this study

Trial Locations (20)

6000

Novartis Investigative Site, Kecskemét

9700

Novartis Investigative Site, Szombathely

16321

Novartis Investigative Site, Bernau

20142

Novartis Investigative Site, Milan

21287

Novartis Investigative Site, Baltimore

32308

Novartis Investigative Site, Tallahassee

33617

Novartis Investigative Site, Bielefeld

50143

Novartis Investigative Site, Florence

53105

Novartis Investigative Site, Bonn

75230

Novartis Investigative Site, Dallas

77694

Novartis Investigative Site, Kehl-Kork

89081

Novartis Investigative Site, Ulm

92001

Novartis Investigative Site, Hlohovec

97517

Novartis Investigative Site, Banská Bystrica

08831

Novartis Investigative Site, Hoffman

H-1097

Novartis Investigative Site, Budapest

041 90

Novartis Investigative Site, Košice

03080

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul