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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
Enrollment 30

Recruitment Details 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 Only subjects who had completed C1073-400 (NCT00569582) were enrolled. All subjects received active drug (no placebo).
Arm/Group Title Open-label
Hide Arm/Group Description mifepristone at doses from 300 mg/day up to 1200 mg/day daily
Period Title: Overall Study
Started 30
Completed 21
Not Completed 9
Arm/Group Title Open-label
Hide Arm/Group Description mifepristone at doses from 300 mg/day up to 1200 mg/day daily
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  90.0%
>=65 years
3
  10.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
46.1  (11.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
20
  66.7%
Male
10
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Subjects who received at least one dose of mifepristone were included in the safety analysis.
Time Frame Up to three years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received one dose of study drug were included in the safety and ITT analyses.
Arm/Group Title Open-label
Hide Arm/Group Description:
mifepristone at doses from 300 mg/day up to 1200 mg/day daily
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
30
2.Secondary Outcome
Title 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
Hide Description

The mean Investigator’s rating of the change in subject’s signs and symptoms of Cushing’s syndrome from Baseline (Entry into C1073-415) to Endpoint on the Physician’s Global Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better). Higher scores indicate more severe illness. Scoring was done at all visits except the 6 Week Follow-up visit; the final visit result (Endpoint) is reported here.

The instruction was "Rate the change in the subject’s signs and symptoms of Cushing’s from Baseline (1 = much better to 9 = much worse)".

Time Frame Up to three years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-label
Hide Arm/Group Description:
mifepristone at doses from 300 mg/day up to 1200 mg/day daily
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.3  (1.74)
Time Frame up to 36 months from entry.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mifepristone 300 to 1200 mg Daily
Hide Arm/Group Description mifepristone at doses from 300 mg/day to 1200 mg/day
All-Cause Mortality
Mifepristone 300 to 1200 mg Daily
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mifepristone 300 to 1200 mg Daily
Affected / at Risk (%) # Events
Total   18/30 (60.00%)    
Cardiac disorders   
Pericarditis  1  1/30 (3.33%)  1
Endocrine disorders   
Adrenal Insufficiency  1  2/30 (6.67%)  2
Gastrointestinal disorders   
Small intestinal obstruction  1  1/30 (3.33%)  1
Immune system disorders   
Amyloidosis  1  1/30 (3.33%)  1
Infections and infestations   
Pneumonia  1  2/30 (6.67%)  2
Arthritis Bacterial  1  1/30 (3.33%)  1
Gastroenteritis  1  1/30 (3.33%)  1
Groin abscess  1  1/30 (3.33%)  1
Subcutaneous abscess  1  1/30 (3.33%)  1
Injury, poisoning and procedural complications   
Hip Fracture  1  1/30 (3.33%)  1
Investigations   
Blood Postassium Decreased  1  4/30 (13.33%)  4
Metabolism and nutrition disorders   
Hyperglycemia  1  1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal chest pain  1  1/30 (3.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma  1  1/30 (3.33%)  1
Malignant melanoma in situ  1  1/30 (3.33%)  1
Oesophageal carcinoma  1  1/30 (3.33%)  1
Uterine leiomyoma  1  1/30 (3.33%)  1
Nervous system disorders   
Amnesia  1  1/30 (3.33%)  1
Cerebral infarction  1  1/30 (3.33%)  1
Cerebrovascular accident  1  1/30 (3.33%)  1
Psychiatric disorders   
Anxiety  1  1/30 (3.33%)  1
Renal and urinary disorders   
Nephrolithiasis  1  1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  1/30 (3.33%)  1
Dyspnoea  1  1/30 (3.33%)  1
Interstitial lung disease  1  1/30 (3.33%)  1
Respiratory Failure  1  1/30 (3.33%)  1
Vascular disorders   
Hypertensive crisis  1  1/30 (3.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mifepristone 300 to 1200 mg Daily
Affected / at Risk (%) # Events
Total   30/30 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1  2/30 (6.67%)  2
Pancytopenia  1  2/30 (6.67%)  2
Cardiac disorders   
Atrioventricular block first degree  1  2/30 (6.67%)  2
Sinus bradycardia  1  4/30 (13.33%)  6
Tachycadia  1  3/30 (10.00%)  3
Endocrine disorders   
Adrenal insufficiency  1  3/30 (10.00%)  3
Cushing's syndrome  1  2/30 (6.67%)  2
Gynaecomastia  1  3/30 (10.00%)  3
Hypothyroidism  1  3/30 (10.00%)  3
Eye disorders   
Cataract nuclear  1  2/30 (6.67%)  3
Diplopia  1  2/30 (6.67%)  2
Vision blurred  1  2/30 (6.67%)  3
Gastrointestinal disorders   
Abdominal pain upper  1  5/30 (16.67%)  6
Nausea  1  15/30 (50.00%)  29
Vomiting  1  7/30 (23.33%)  14
Abdominal discomfort  1  2/30 (6.67%)  2
Abdominal distension  1  2/30 (6.67%)  2
Abdominal pain  1  3/30 (10.00%)  3
Constipation  1  3/30 (10.00%)  3
Diarrhoea  1  3/30 (10.00%)  4
Toothache  1  2/30 (6.67%)  2
General disorders   
Fatique  1  12/30 (40.00%)  14
Oedema peripheral  1  7/30 (23.33%)  10
Chest pain  1  2/30 (6.67%)  4
Infections and infestations   
Nasopharyngitis  1  6/30 (20.00%)  7
Upper respiratory tract infection  1  6/30 (20.00%)  7
Pneumonia  1  3/30 (10.00%)  3
Sinusitis  1  2/30 (6.67%)  2
Urinary tract infection  1  4/30 (13.33%)  7
Vulvovaginal mycotic infection  1  3/30 (10.00%)  3
Injury, poisoning and procedural complications   
Contusion  1  3/30 (10.00%)  3
Skin laceration  1  2/30 (6.67%)  2
Investigations   
Blood potassium decreased  1  14/30 (46.67%)  46
Thyroid function test abnormal  1  6/30 (20.00%)  6
Androgens increased  1  2/30 (6.67%)  3
Blood cholesterol increased  1  4/30 (13.33%)  4
Blood corticotrophin increased  1  2/30 (6.67%)  2
Blood creatinine increased  1  2/30 (6.67%)  2
Blood potassium increased  1  2/30 (6.67%)  3
Blood testosterone free increased  1  3/30 (10.00%)  4
Blood testosterone increased  1  3/30 (10.00%)  3
Electrocardiogram QT prolonged  1  3/30 (10.00%)  3
Protein urine  1  2/30 (6.67%)  2
Urine cortisol / creatinine ratio increased  1  2/30 (6.67%)  3
White blood cell count increased  1  2/30 (6.67%)  2
Metabolism and nutrition disorders   
Decreased appetite  1  3/30 (10.00%)  4
Dyslipidaemia  1  2/30 (6.67%)  2
Hypoglycaemia  1  3/30 (10.00%)  4
Vitamin D deficiency  1  2/30 (6.67%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/30 (6.67%)  3
Back pain  1  5/30 (16.67%)  5
Joint swelling  1  2/30 (6.67%)  3
Muscle spasms  1  3/30 (10.00%)  4
Musculoskeletal chest pain  1  2/30 (6.67%)  5
Musculoskeletal pain  1  4/30 (13.33%)  5
Myalgia  1  2/30 (6.67%)  2
Osteopenia  1  2/30 (6.67%)  2
Osteoporosis  1  2/30 (6.67%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Pituitary tumor benign  1  3/30 (10.00%)  4
Uterine leiomyoma  1  2/30 (6.67%)  2
Nervous system disorders   
Headache  1  11/30 (36.67%)  22
Dizziness  1  7/30 (23.33%)  9
Muscular weakness  1  2/30 (6.67%)  3
Psychiatric disorders   
Anxiety  1  3/30 (10.00%)  3
Depression  1  3/30 (10.00%)  5
Insomnia  1  4/30 (13.33%)  4
Panic attack  1  2/30 (6.67%)  2
Sleep disorder  1  2/30 (6.67%)  3
Renal and urinary disorders   
Nephrolithiasis  1  3/30 (10.00%)  3
Pollakiuria  1  2/30 (6.67%)  2
Reproductive system and breast disorders   
Endometrial disorder  1  4/30 (13.33%)  7
Endometrial hypertrophy  1  10/30 (33.33%)  12
Metrorrhagia  1  4/30 (13.33%)  5
Ovarian cyst  1  2/30 (6.67%)  4
Vaginal haemorrhage  1  4/30 (13.33%)  8
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/30 (10.00%)  4
Dyspnoea  1  2/30 (6.67%)  4
Pharyngolaryngeal pain  1  2/30 (6.67%)  3
Skin and subcutaneous tissue disorders   
Skin discolouration  1  2/30 (6.67%)  2
Vascular disorders   
Hot flush  1  2/30 (6.67%)  2
Hypertension  1  9/30 (30.00%)  14
Hypotension  1  2/30 (6.67%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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.
Results Point of Contact
Name/Title: Medical Director
Organization: Corcept Therapeutics
Phone: 650-327-3270
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