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Clinical Trials/NCT03379363
NCT03379363
Terminated
Not Applicable

Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome

Corcept Therapeutics1 site in 1 country2 target enrollmentSeptember 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypercortisolism
Sponsor
Corcept Therapeutics
Enrollment
2
Locations
1
Primary Endpoint
Drug utilization patterns as assessed by chart review
Status
Terminated
Last Updated
6 years ago

Overview

Brief Summary

This retrospective, multi-center, chart review study will collect patient data from medical charts of pediatric patients who have been treated with Korlym for Cushing's syndrome.

Detailed Description

This retrospective chart review study seeks to collect data from pediatric patients treated with Korlym (mifepristone) to help provide clinicians with some insight on the potential role of mifepristone in the treatment of pediatric patients with Cushing syndrome. Only sites that have been identified to have patients appropriate for this protocol will be invited to participate and contribute data on their patients Data to be collected from a retrospective chart review will include: * Patient demographics * Medical history * Pre and post treatment clinical assessments and laboratory results * Radiologic findings (if available) * Adverse events Data will be collected for all follow-up visits, up until the most recent encounter prior to IRB approval.

Registry
clinicaltrials.gov
Start Date
September 18, 2017
End Date
February 12, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Pediatrics (age≤21 years) at time Korlym initiation
  • Considered to have a diagnosis of endogenous Cushing's syndrome by the healthcare provider
  • Received at least one dose of Korlym
  • Availability of pre-treatment (baseline) and follow-up data

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Drug utilization patterns as assessed by chart review

Time Frame: Length of Korlym therapy, up to 5 years

The retrospective review would analyze the drug utilization patterns of pediatric patients treated with Korlym

Secondary Outcomes

  • Weight as assessed by chart review(Length of Korlym therapy, up to 5 years)
  • Blood Pressure as assessed by chart review(Length of Korlym therapy, up to 5 years)

Study Sites (1)

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