Clinical Trial Details

NCT ID: NCT02060383
Date Last Changed: October 12, 2017

Overview

Research Study Summary

A clinical research study for the treatment of Cushing's Disease, or Acromegaly

Research Study Title

A Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or Acromegaly

Purpose

The study aims to demonstrate that pasireotide-induced hyperglycemia can be effectively and safely managed in majority of patients, including those with diabetes at start of pasireotide treatment.

To Learn more

Recruitment Details

Phase
4
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Novartis Pharmaceuticals
Duration
49 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • Patients greater than or equal to 18 years old

  • Confirmed diagnosis of Cushing's disease or acromegaly

Exclusion Criteria:

  • Patients who require surgical intervention

  • Patients receiving DPP-4 inhibitors or GLP-1 receptor agonists within 4 weeks prior to study entry

  • HbA1c > 10 % at screening

  • Known hypersensitivity to somatostatin analogues Other protocol-defined inclusion/exclusion criteria may apply.

Site Locations (15)

Country State City Zip Facility and Contact
United States California Multiple Locations Diabetes and Endocrine Associates La Mesa Location
Denise Humphries
619-466-4899
dmendo1@pacbell.net

Raymond Fink
Principal Investigator
United States California Torrance 90502 LA Biomedical Research at Harbor UCLA Medical Center SC - SOM230B2219
Elizabeth Ruiz
310-222-1728
eruiz@labiomed.org

Ronald Swerdloff
Principal Investigator
United States California Ventura 93003 Coastal Metabolic Research Centre SC
Gabriel Garcia
805-658-8460
g5garcia@yahoo.com

Ronald H. Chochinov
Principal Investigator
United States Florida Jacksonville 32223 East Coast Institute for Research East Coast Inst. for Res(ECIR)
Miriam Green
Miriam.Green@eastcoastresearch.net

Mae Sheikh-Ali
Principal Investigator
United States Missouri Saint Louis 63110 Washington University SC - SOM230B2411
Mary Jane Clifton
314-747-3294
mclifton@wustl.edu

Julie Silverstein
Principal Investigator
United States Montana Great Falls 59405 Great Falls Clinic Great Falls Clinic
Patty Bowman
406-771-3373
patty.bowman@gfclinic.com

Barry Cohan
Principal Investigator
United States New Jersey New Brunswick 08901 Robert Wood Johnson Medical School - Rutgers SC
Deborah A. McCloskey
732-418-8484
mcclosda@rwjms.rutgers.edu

Sara Lubitz
Principal Investigator
United States New York New York 10029 The Mount Sinai Hospital SC
Vanessa L Cohen
212-241-8903
cohenv@mskcc.org

Eliza B. Geer
Principal Investigator
United States New York New York 10032 Columbia University Medical Center- New York Presbyterian Neuroendocrine Unit
Carlos C. Reyes-Vidal
212-305-4921
csr52@cumc.columbia.edu

Pamela U. Freda
Principal Investigator
United States New York New York 10075 Lenox Hill Hospital/Manhattan Eye, Ear and Throat Hospital SC
Tamika Wong
Twong4@northwell.edu

John Boockvar
Principal Investigator
United States Pennsylvania Pittsburgh 15212 Allegheny Endocrinology Associates SC
Ann Minnock
aminnock@aghendo.com

Murray B Gordon
Principal Investigator
United States Tennessee Nashville 37212-8210 Vanderbilt Clinical Trials Center SOM230B2219
Sheri L. Dixon
615-343-0266
sheri.dixon@vanderbilt.edu

Andrea L. Utz
Principal Investigator
United States Texas Houston 77030 Baylor College of Medicine Ben Taub General Hosp.
Betsy Staudinger
713-873-8772
stauding@bcm.edu

Susan L. Samson
Principal Investigator
United States Virginia Chesapeake 23321 Virginia Endocrinology Research SC-2
Vicki M. Maine
vmaine@VaEndoResearch.org

James LaRocque
Principal Investigator
United States Washington Seattle 98122-4379 Swedish Medical Center Dept.ofSeattle Neuroscience(2)
Yuriko Courtney
206-320-7115
yuriko.courtney@swedish.org

Zachary Litvak
Principal Investigator

Contact

Novartis Pharmaceuticals
1-888-669-6682
E-mail:

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