drugset / Trial / NCT03277690

A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.

NCT03277690

Phase 3 Completed 84 enrolled Cortendo AB
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous Cushing's Syndrome (CS) previously treated with single-arm, open-label levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of levoketoconazole.

Timeline

Start
2017-09-26
Primary completion
2020-06-30
Completion
2020-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Levoketoconazole Unknown 1200 mg