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Last Updated: April 13, 2024

CLINICAL TRIALS PROFILE FOR LEVOKETOCONAZOLE


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All Clinical Trials for Levoketoconazole

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01838551 ↗ Treatment for Endogenous Cushing's Syndrome Completed Cortendo AB Phase 3 2014-08-01 The primary objectives of this study are to evaluate the clinical responder rate, defined as the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the Maintenance Phase without dose increase, and to evaluate the range of effective doses in subjects with various levels of hypercortisolism.
NCT03277690 ↗ A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome. Completed Cortendo AB Phase 3 2017-09-26 This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous CS previously treated with single-arm, open-label levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of levoketoconazole.
NCT03621280 ↗ Open-label Treatment in Cushing's Syndrome Active, not recruiting Cortendo AB Phase 3 2019-01-07 This is a long-term, open-label extension study of levoketoconazole in subjects with endogenous Cushing's Syndrome.
NCT03768388 ↗ Levoketoconazole Food Effect Study in Healthy Subjects Completed Cortendo AB Phase 1 2018-11-30 This is a phase I, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the effect of food on the PK of levoketoconazole.
NCT03880825 ↗ Drug Interaction Study of Levoketoconazole and Metformin Completed Cortendo AB Phase 1 2019-03-28 This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the effect of levoketoconazole on the single-dose PK of metformin in health subjects.
NCT04212000 ↗ Bioavailability of Levoketoconazole and Ketoconazole Tablets Completed Cortendo AB Phase 1 2019-12-16 This is a phase 1, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the relative oral bioavailability of levoketoconazole tablets (the test drug) and ketoconazole tablets (the reference drug product).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Levoketoconazole

Condition Name

Condition Name for Levoketoconazole
Intervention Trials
Endogenous Cushing's Syndrome 2
Healthy Subjects 2
Cushing Disease 1
Cushing Syndrome 1
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Condition MeSH

Condition MeSH for Levoketoconazole
Intervention Trials
Syndrome 3
Cushing Syndrome 3
Pituitary ACTH Hypersecretion 1
ACTH-Secreting Pituitary Adenoma 1
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Clinical Trial Locations for Levoketoconazole

Trials by Country

Trials by Country for Levoketoconazole
Location Trials
United States 38
Spain 5
Romania 4
Netherlands 3
Italy 3
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Trials by US State

Trials by US State for Levoketoconazole
Location Trials
Florida 5
Oregon 3
New York 3
Michigan 3
Maryland 3
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Clinical Trial Progress for Levoketoconazole

Clinical Trial Phase

Clinical Trial Phase for Levoketoconazole
Clinical Trial Phase Trials
Phase 3 3
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Levoketoconazole
Clinical Trial Phase Trials
Completed 5
Active, not recruiting 1
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Clinical Trial Sponsors for Levoketoconazole

Sponsor Name

Sponsor Name for Levoketoconazole
Sponsor Trials
Cortendo AB 6
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Sponsor Type

Sponsor Type for Levoketoconazole
Sponsor Trials
Industry 6
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