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NCT06430528 · ClinicalTrials.gov registry record
A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
A clinical trial of Adrenal Insufficiency and Hypercortisolism, sponsored by University of Michigan.
- Recruiting
- Registry status
- 12
- Enrollment target
- 1
- Study location
NCT06430528: Recruiting study of Adrenal Insufficiency and Hypercortisolism, sponsored by University of Michigan.
NCT06430528 is a study of Adrenal Insufficiency and Hypercortisolism that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 12 participants, below the 3,065-participant average among 5 other Adrenal Insufficiency trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06430528, a study of Adrenal Insufficiency and Hypercortisolism, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach). The investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment.
Primary Outcome
based on evidence of hypotension (systolic BP \<90 mmHg) and/or hypoglycemia (glucose \<45 mg/dL) with antecedent symptoms (examples: anorexia, nausea, abdominal pain, orthostasis) and with a resolution of signs upon receiving rescue glucocorticoid therapy
Conditions Studied
Interventions
- DRUG Osilodrostat
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-07-19 |
| Est. Completion | 2027-08 |
What NCT06430528 shows while recruiting
NCT06430528 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 3,065-participant average among 5 other Adrenal Insufficiency trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Adrenal Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which Osilodrostat is the first listed.
NCT06430528 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06430528 about?
NCT06430528 is a clinical study titled "A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement". The major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach). The investigators are also evaluating new biomarker steroids ...
What is the current status of trial NCT06430528?
This trial is currently recruiting. The enrollment target is 12 participants. The study started on 2024-07-19. Estimated completion is 2027-08.
What conditions does trial NCT06430528 study?
This clinical trial studies the following conditions: Adrenal Insufficiency, Hypercortisolism, Endogenous Cushing Syndrome.
What interventions are being tested in trial NCT06430528?
The interventions under investigation include: Osilodrostat (DRUG).
Who is sponsoring clinical trial NCT06430528?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06430528 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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