Glucocorticoid Receptor Antagonism in Subclinical Cushings
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT00721201
Collaborator
HRA Pharma (Industry)
6
1
15.9
0.4
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the effects of reducing the activity of endogenous glucocorticoid in patients with low-grade cortisol excess
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
6 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of the Effect of a Glucocorticoid Receptor Antagonist in Patients With Subclinical Cushings
Study Start Date
:
Nov 1, 2008
Actual Primary Completion Date
:
Mar 1, 2010
Actual Study Completion Date
:
Mar 1, 2010
Outcome Measures
Primary Outcome Measures
- Blood pressure [8 weeks]
Secondary Outcome Measures
- Glucose homeostasis [8 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients will be eligible for inclusion if: they are males and over 18, lack clinical features classically associated with Cushing's syndrome; have evidence of excess circulating cortisol
Exclusion Criteria:
- Evidence of local or systemic malignancy; overt Cushing's syndrome; severe uncontrolled diabetes mellitus or hypertension; pregnancy; clinically significantly impaired cardiovascular function (e.g. stage IV cardiac failure); severe liver disease (liver enzymes ≥ 3 x the institutional upper limit of normal range); significantly impaired renal function (eGFR <30/min); uncontrolled severe active infection; treatment with approved or experimental steroidogenesis inhibitors, adrenolytic agents, within four weeks of admission; In women, known endometrial cancer, history of endometrial hyperplasia or vaginal bleeding of unknown cause; requirement for inhaled or systemic glucocorticoids for existing disease; impaired mental capacity or markedly abnormal psychiatric evaluation that precludes informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | United Kingdom |
Sponsors and Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- HRA Pharma
Investigators
- Principal Investigator: Dr John Newell Price, University of Sheffield
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00721201
Other Study ID Numbers:
- STH14791
First Posted:
Jul 23, 2008
Last Update Posted:
Jan 26, 2021
Last Verified:
Jan 1, 2021