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Trial record 15 of 15 for:    "Acth-Secreting Pituitary Adenoma" | "Hydrocortisone acetate"

A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome (SEISMIC)

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: NCT00569582
Recruitment Status : Completed
First Posted : December 7, 2007
Results First Posted : May 28, 2012
Last Update Posted : August 22, 2013
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 50
Recruitment Details 24 week multicenter, open-label trial after failed multimodality therapy at 14 U.S. academic medical centers and three private research centers.
Pre-assignment Details Adults with endogenous Cushing's Syndrome associated with either type 2 diabetes mellitus/impaired glucose tolerance or a diagnosis of hypertension.
Arm/Group Title Mifepristone
Hide Arm/Group Description Mifepristone was administered at doses of 300-1200 mg daily.
Period Title: Overall Study
Started 50
Completed 34
Not Completed 16
Reason Not Completed
Withdrawal by Subject             5
Death             2
Adverse Event             7
Subject was too ill to travel.             1
Subject was non-compliant.             1
Arm/Group Title Mifepristone
Hide Arm/Group Description Mifepristone was administered at doses of 300-1200 mg daily.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
0
   0.0%
Between 18 and 65 years
46
  92.0%
>=65 years
4
   8.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
45.4  (11.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
35
  70.0%
Male
15
  30.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Improvement in Diabetes and/or Glucose Intolerance.
Hide Description Responder is defined as subject with a decrease greater than or equal to 25% in area under the curve for glucose on 2-hour oral glucose test from baseline to week 24 or last visit, for Cushing's patients with type-2 diabetes mellitus/impaired glucose tolerance.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with at least 30 days of dosing.
Arm/Group Title Mifepristone
Hide Arm/Group Description:
Mifepristone was administered at doses of 300-1200 mg daily.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
15
2.Primary Outcome
Title Decrease in Diastolic Blood Pressure.
Hide Description Responder is defined as subject with a decrease greater than or equal to 5mm Hg in diastolic blood pressure from baseline to week 24 or last visit.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone
Hide Arm/Group Description:
Mifepristone was administered at doses of 300-1200 mg daily.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
8
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mifepristone
Hide Arm/Group Description Mifepristone was administered at doses of 300-1200 mg daily.
All-Cause Mortality
Mifepristone
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mifepristone
Affected / at Risk (%) # Events
Total   16/50 (32.00%)    
Cardiac disorders   
Cardiomyopathy  1  1/50 (2.00%)  1
Angina Pectoris  1  1/50 (2.00%)  1
Endocrine disorders   
Adrenal Insufficiency  1  1/50 (2.00%)  1
Gastrointestinal disorders   
Gastritis Erosive  1  1/50 (2.00%)  1
Vomiting  1 [1]  1/50 (2.00%)  1
General disorders   
Asthenia  1  1/50 (2.00%)  2
Infections and infestations   
Legionella pneumonia  1  1/50 (2.00%)  1
Sinusitis  1  1/50 (2.00%)  1
Subcutaneous Abscess  1  1/50 (2.00%)  1
Injury, poisoning and procedural complications   
Foot Fracture  1  1/50 (2.00%)  1
Investigations   
Blood Potassium Decreased  1  1/50 (2.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
adrenal carcinoma  1  2/50 (4.00%)  2
neoplasm progression  1  1/50 (2.00%)  1
neuroendocrine carcinoma  1  1/50 (2.00%)  1
Nervous system disorders   
Intracranial Aneurysm  1  1/50 (2.00%)  1
Psychiatric disorders   
Confusional State  1  1/50 (2.00%)  1
Renal and urinary disorders   
Renal Failure Acute  1  1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/50 (2.00%)  2
Respiratory Failure  1  2/50 (4.00%)  2
Pulmonary Oedema  1  1/50 (2.00%)  1
Pulmonary Embolism  1  1/50 (2.00%)  1
Vascular disorders   
Orthostatic Hypotension  1  1/50 (2.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDRA
[1]
severe
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mifepristone
Affected / at Risk (%) # Events
Total   49/50 (98.00%)    
Endocrine disorders   
Cushing’s syndrome  1  4/50 (8.00%)  6
Eye disorders   
Vision blurred  1  4/50 (8.00%)  5
Gastrointestinal disorders   
Nausea  1  24/50 (48.00%)  40
Vomiting  1  13/50 (26.00%)  21
Dry mouth  1  9/50 (18.00%)  12
Diarrhoea  1  6/50 (12.00%)  8
Constipation  1  5/50 (10.00%)  5
Gastrooesophageal reflux disease  1  4/50 (8.00%)  4
General disorders   
Fatigue  1  24/50 (48.00%)  37
Oedema peripheral  1  13/50 (26.00%)  31
Pain  1  7/50 (14.00%)  9
Asthenia  1 [1]  3/50 (6.00%)  5
Malaise  1  3/50 (6.00%)  4
Oedema  1  3/50 (6.00%)  6
Pitting oedema  1  3/50 (6.00%)  4
Thirst  1  3/50 (6.00%)  3
Infections and infestations   
Sinusitis  1  7/50 (14.00%)  9
Nasopharyngitis  1  6/50 (12.00%)  10
Urinary tract infection  1  4/50 (8.00%)  5
Upper respiratory tract infection  1  3/50 (6.00%)  5
Injury, poisoning and procedural complications   
Contusion  1  3/50 (6.00%)  4
Investigations   
Blood potassium decreased  1  17/50 (34.00%)  27
Thyroid function test abnormal  1  9/18 (50.00%)  11
Blood triglycerides increased  1  4/50 (8.00%)  5
Metabolism and nutrition disorders   
Decreased appetite  1  10/20 (50.00%)  12
Anorexia  1  5/50 (10.00%)  6
Hypoglycaemia  1  3/50 (6.00%)  4
Hypertension  1  12/50 (24.00%)  14
Hot flush  1  3/50 (6.00%)  3
Musculoskeletal and connective tissue disorders   
Arthralgia  1  15/50 (30.00%)  20
Back pain  1  8/50 (16.00%)  9
Myalgia  1  7/50 (14.00%)  11
Pain in extremity  1  6/50 (12.00%)  6
Muscular weakness  1  4/50 (8.00%)  6
Flank pain  1  3/50 (6.00%)  3
Musculoskeletal chest pain  1  3/50 (6.00%)  4
Nervous system disorders   
Headache  1  22/50 (44.00%)  40
Dizziness  1  11/50 (22.00%)  20
Somnolence  1  5/50 (10.00%)  7
Psychiatric disorders   
Anxiety  1  5/50 (10.00%)  12
Insomnia  1  3/50 (6.00%)  5
Renal and urinary disorders   
Pollakiuria  1  3/50 (6.00%)  3
Reproductive system and breast disorders   
Vaginal haemorrhage  1  4/50 (8.00%)  4
Metrorrhagia  1  3/50 (6.00%)  8
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1 [2]  8/50 (16.00%)  11
Pharyngolaryngeal pain  1  4/50 (8.00%)  4
Cough  1  3/50 (6.00%)  4
Skin and subcutaneous tissue disorders   
Dry skin  1  4/50 (8.00%)  5
Ecchymosis  1  4/50 (8.00%)  4
Acne  1  3/50 (6.00%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDRA
[1]
mild
[2]
mild or moderate
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Corcept Therapeutics
Phone: 650-327-3270
EMail: info@corcept.com
Layout table for additonal information
Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00569582     History of Changes
Other Study ID Numbers: C-1073-400
First Submitted: December 5, 2007
First Posted: December 7, 2007
Results First Submitted: April 4, 2012
Results First Posted: May 28, 2012
Last Update Posted: August 22, 2013