Last updated on November 2017

An Open Label Study to Assess the Safety and Efficacy of COR-003 (2S, 4R ketoconazole) in the Treatment of Endogenous Cushing's Syndrome


Brief description of study

An Open Label Study to Assess the Safety and Efficacy of COR-003 (2S, 4R ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

Detailed Study Description

The primary objectives of this study are to evaluate the efficacy of ascending doses of COR-003 in subjects with elevated levels of cortisol due to endogenous Cushing's Syndrome by assessment of reduction in Urinary Free Cortisol (UFC) concentrations and to identify the range of safe and effective doses of COR-003 that reduce mean UFC concentrations ≤ULN (upper limit of normal) of the assay at month 6 of the maintenance phase of dosing without a prior dose increase in that phase.

Clinical Study Identifier: TX3053

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Hilde Morobé

UZLeuven Dienst endocrinologie
Leuven, XX Belgium

Karen J. P. Liebert, BSN, ...

Massachusetts General Hospital
Boston, MA USA

Mouna Sahnoun-Fathallah, SC

Hôpital de la TIMONE Department of Endocrinology and Reference Center for Rare Pituitary Diseases
Marseille, XX France

Elisabeth Combeau

Endocrinologie, Pavillon des Ecrins Centre Hospitalier Universitaire, Hopital Nord
Cedex, XX France

Angeles Martorell

Hospital Universitario de la Ribera Centre Hospitalier Universitaire, Hopital Nord
Alzira-Valencia, XX Spain

Sjaan Poldermans

Erasmus MC, Dpt. Of Internal Medicine, Division of Endocrinology Centre Hospitalier Universitaire, Hopital Nord
Rotterdam, XX Netherlands

Shirley McCartney

Oregon Health & Science University
Portland, OR USA

Elizabeth Baez, MA

Icahn School of Medicine at Mount Sinai
New York, NY USA

Andreea Mocanu

Cleveland Clinic Endocrinology
Cleveland, OH USA

Angela Howell

CarePoint East
Columbus, OH USA

Oyinkan Kusemiju, MPH

Johns Hopkins University School of Medicine Division of Endocrinology, Diabetes & Metabolism
Baltimore, MD USA

Liat Rot

Institute of Endocrinology & Metabolism Rabin Medical Center, Beilinson Campus
Petah Tiqva, XX Israel

Helen Peachey

University of Pennslyvania Smilow Center for Translational Research
Philadelphia, PA USA

Olga Roig

Hospital Sant Pau, Universitat Autònoma de Barcelona
Barcelona, XX Spain

Laurence Guignat, MD

Centre de Réference Maladies Rares de la Surrénale, Service d'Endocrinologie, Hôpital Cochin
Paris, XX France

Carole Ramm, MS

University of Michigan Medical Center Rares de la Surrénale, Service d'Endocrinologie, Hôpital Cochin
Ann Arbor, MI USA

Michele A. Spear, MC/MFCT, CCRC

University of New Mexico HSC
Albuquerque, NM USA

Giorgia Marcelli

Clinica di Endocrinologia e del Metabolismo
Ancona, XX Italy

Jasmin Abdalla

Leiden University, Leiden University Medical Center, Dept. of Endocrinology
Leiden, XX Netherlands

Jessica Rios-Santiago

Coastal Metabolic Research Center University Medical Center, Dept. of Endocrinology
Ventura, CA USA

Thea Christoffersen

Copenhagen University Hospital
Copenhagen, XX Denmark

Betsy Parrott, RN, CCRC

Rhode Island Hospital, Hallett Center for Diabetes and Endocrinology
East Providence, RI USA

Adrine Gdakian

UCLA School of Medicine
Los Angeles, CA USA

Cyndi Serpico

Advanced Research
Peoria, AZ USA

Suzanne Dallaire

Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, XX Canada

Dr.ssa Monica De Leo

Department of Molecular and Clinical Endocrinology and Oncology, University of Naples Federico II
Naples, XX Italy

Lone Vad

Aarhus University Hospital
Aarhus, XX Denmark

Sarah Cazenave

Attachée de Recherche Clinique Service d'Endocrinologie, Diabétologie, Maladies Métaboliques et Nutrition Hôpital du Haut-Lévêque
Pessac cedex, XX France

Dr. Paola Perotti

SCDU Medicina Interna I Università di Torino Dipartimento di Scienze Cliniche e Biologiche
Orbassano, XX Italy

Rowan Challis

The Christie NHS Foundation Trust
Manchester, XX United Kingdom

Crystal Gagnon

St. Paul's Hospital/Vancouver General Hospital
Vancouver, XX Canada

Ms. Dora Monteyne

Universitair Ziekenhuis
Brussel, XX Belgium

Ms. Dora Monteyne

Universitair Ziekenhuis
Brussels, XX Belgium

Becky Wood, CCRP

Swedish Neuroscience Research
Seattle, WA USA