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NCT02663609 Clinical Trial

Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome

Cushing's Syndrome Clinical Trial

— RE-KLAIM  

Official title:
Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02663609
Other study ID # C1073-450
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2015
Est. completion date December 1, 2017

Study information
Verified date May 2023
Source Corcept Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Chart review study to collect patient data from medical charts of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome.

Description:

A retrospective, multi-center, chart review study to collect patient data from medical charts of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome. Treatment with Korlym® will be a minimum 3 months in duration with follow-up of a minimum 3 months. Only sites that have been identified to have patients appropriate for this protocol will be invited to participate.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date December 1, 2017
Est. primary completion date December 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Diagnosed with ACTH independent endogenous Cushing's Syndrome - Available adrenal imaging prior to being treated with Korlym® - Treated with Korlym® and followed for at least 3 months (follow-up data should be available) Exclusion Criteria: - Diagnosed with adrenocortical carcinoma - Participant in any clinical trial(s) during the observational period

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No treatment (intervention) was administered.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Corcept Therapeutics

Outcome
Type Measure Description Time frame Safety issue
Primary Drug Utilization Patterns as assessed by chart review The retrospective review would analyze the drug utilization patterns of patients treated with Korlym up to 4 years
Secondary Clinical Outcomes as assessed by chart review The retrospective review would analyze outcomes measures (vitals, clinical assessments, etc) in patients treated with Korlym up to 4 years
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