Hypercortisolism related to benign adrenal tumour
Conditions
Brief summary
"an evaluation of the benefit-risk profile of SPI-62 consisting of laboratory data, incidence of treatment emergent adverse events (TEAEs), progression, or regression, of underlying disease or its complications"
Detailed description
"short-term progression, persistence, improvement, or resolution of clinical signs, markers, and symptom of hypercortisolism including: hyperglycemia, dyslipidemia, osteopenia, hypertension, and other features associated with endogenous hypercortisolism. Long-term safety relating to serious morbidity or mortality"
Interventions
None listed
Sponsors
Sparrow Pharmaceuticals Inc., Sparrow Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| "short-term progression, persistence, improvement, or resolution of clinical signs, markers, and symptom of hypercortisolism including: hyperglycemia, dyslipidemia, osteopenia, hypertension, and other features associated with endogenous hypercortisolism. Long-term safety relating to serious morbidity or mortality" | — |
Primary
| Measure | Time frame |
|---|---|
| "an evaluation of the benefit-risk profile of SPI-62 consisting of laboratory data, incidence of treatment emergent adverse events (TEAEs), progression, or regression, of underlying disease or its complications" | — |
Countries
Romania
Outcome results
None listed