NCT03379363

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2018

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

October 24, 2017

Last Update Submit

July 26, 2019

Conditions

HypercortisolismCushing Syndrome

Keywords

cushing syndrome, hypercortisolism

Outcome Measures

Primary Outcomes (1)

  • Drug utilization patterns as assessed by chart review

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

    Length of Korlym therapy, up to 5 years

Secondary Outcomes (2)

  • 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 Arms (1)

Pediatric Cushing Syndrome Patients

Pediatrics patients with endogenous Cushing syndrome who received at least one dose of Korlym

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients who have been treated with Korlym for Cushing's syndrome

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corcept Therapeutics

Menlo Park, California, 94025, United States

Location

MeSH Terms

Conditions

Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

December 20, 2017

Study Start

September 18, 2017

Primary Completion

February 12, 2018

Study Completion

February 12, 2018

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)