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

  • STATUS
    Not Recruiting
  • sponsor
    Cortendo AB
Updated on 21 April 2022

Summary

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

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.

Details
Condition Cushing's Disease, Acromegaly
Clinical Study IdentifierTX139308
SponsorCortendo AB
Last Modified on21 April 2022

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