60
Participants
Start Date
January 17, 2008
Primary Completion Date
September 21, 2010
Study Completion Date
September 25, 2017
Placebo
Matching placebo tablets were administered orally once daily.
Obeticholic Acid (OCA)
Starting dose of 10 or 50 mg administered orally once daily, followed by dose titration planned from 10 mg to 25 mg to 50 mg once daily, which could be modified for safety and tolerability issues or to achieve adequate therapeutic response.
Karls-Franzens University, Graz
University Medical Centre Hamburg-Eppendorf, Hamburg
Virginia Commonwealth University, Richmond
Medical School of Hannover, Hanover
Henry Ford, Detroit
Johann Wolfgang Goethe University, Frankfurt
Hopital de l'Hotel Dieu, Lyon
Hopital Saint-Antoine, Paris
Baylor College of Medicine, Houston
University of Munich, Munich
Virginia Mason Medical Center, Seattle
University of Alberta, Edmonton
University of Toronto, Toronto
Centre de Recherche du CHUM / University of Montreal, Montreal
Hospital Clinic i Provincial, Barcelona
Queen Elizabeth Medical Center, Edgbaston
Royal Free Hospital, Hampstead
John Radcliffe Hospital, Headington
Royal Infirmary, Edinburgh
Sunderland Research Ethics Committee, Jarrow
University Upon Tyne/Newcastle, Newcastle upon Tyne
Lead Sponsor
Intercept Pharmaceuticals
INDUSTRY