CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 84 enrolled
Drug / intervention
Levoketoconazole +1 moredrug
Likely dose
Levoketoconazole 1200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03277690
NCT03277690Phase 3Completed
CompareCT.gov

A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open Label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S, 4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

Cortendo AB·interventional·Posted Sep 11, 2017·Updated Nov 8, 2022

In Brief

A Phase 3 clinical trial evaluating Levoketoconazole and Placebo for Endogenous Cushing's Syndrome. Completed, enrolled 84 participants across 45 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndogenous Cushing's Syndrome
CountriesBulgaria, Denmark, France, Greece, Hungary, Israel, Italy, Netherlands, Poland, Romania, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 11, 2017
Enrollment StartSep 26, 2017
Primary CompletionJun 30, 2020
Study CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.8 years ago

Interventions

Levoketoconazoledrug

During the double-blind Withdrawal Phase, patients will receive up to 1200 mg levoketoconazole daily. During the double-blind Restoration Phase, patients will receive levoketoconazole plus placebo.

Placebodrug

During the double-blind Withdrawal Phase, patients will receive placebo tablets. During the double-blind Restoration Phase, patients will receive placebo plus levoketoconazole.