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

NCT02150213 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2016-12-05

Study results available
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Summary

To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).

Conditions

  • Adrenocortical Adenoma
  • Endometrial 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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States
  • Germany
  • Hungary
  • Italy
  • Slovakia
  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02150213 on ClinicalTrials.gov