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An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome

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ClinicalTrials.gov Identifier: NCT00936741
Recruitment Status : Completed
First Posted : July 10, 2009
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cushing's Syndrome
Intervention: Drug: mifepristone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects completing 24 weeks of mifepristone treatment under Corcept protocol C1073-400 (NCT00569582) were eligible to continue treatment in C1073-415 at the dose being administered at the end of treatment in C1073-400 (NCT00569582).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only subjects who had completed C1073-400 (NCT00569582) were enrolled. All subjects received active drug (no placebo).

Reporting Groups
  Description
Open-label mifepristone at doses from 300 mg/day up to 1200 mg/day daily

Participant Flow:   Overall Study
    Open-label
STARTED   30 
COMPLETED   21 
NOT COMPLETED   9 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Open-label mifepristone at doses from 300 mg/day up to 1200 mg/day daily

Baseline Measures
   Open-label 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   27 
>=65 years   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.1  (11.74) 
Gender 
[Units: Participants]
 
Female   20 
Male   10 
Region of Enrollment 
[Units: Participants]
 
United States   30 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: Up to three years. ]

2.  Secondary:   The Long-term Benefit of Mifepristone Treatment in Cushing’s Syndrome as Measured by Changes in the Score on the Physician’s Global Assessment of Disease Severity   [ Time Frame: Up to three years. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Corcept Therapeutics
phone: 650-327-3270
e-mail: info@corcept.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00936741     History of Changes
Other Study ID Numbers: C-1073-415
First Submitted: July 9, 2009
First Posted: July 10, 2009
Results First Submitted: September 18, 2013
Results First Posted: April 2, 2014
Last Update Posted: April 2, 2014