Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome (RE-KLAIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02663609
Recruitment Status : Completed
First Posted : January 26, 2016
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Brief 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.

Condition or disease Intervention/treatment
Cushing's Syndrome Other: No intervention

Detailed 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome
Study Start Date : October 2015
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 1, 2017



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


Primary Outcome Measures :
  1. Drug Utilization Patterns as assessed by chart review [ Time Frame: up to 4 years ]
    The retrospective review would analyze the drug utilization patterns of patients treated with Korlym


Secondary Outcome Measures :
  1. Clinical Outcomes as assessed by chart review [ Time Frame: up to 4 years ]
    The retrospective review would analyze outcomes measures (vitals, clinical assessments, etc) in patients treated with Korlym



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ACTH Independent Cushing's Syndrome patients treated with Korlym® mifepristone) as standard of care in clinical practice.
Criteria

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
Layout table for additonal information
Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT02663609    
Other Study ID Numbers: C1073-450
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Corcept Therapeutics:
Cushing's Syndrome
Mifepristone
Adrenal
Retrospective
Chart Review
Additional relevant MeSH terms:
Layout table for MeSH terms
Cushing Syndrome
Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases