patients with adrenal incidentalomas and subclinical/mild Cushing’s syndrome MedDRA version: 20.0 Level: PT Classification code 10011652 Term: Cushing's syndrome System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: CORMETO - "250 MG CAPSULE MOLLI" 50 CAPSULE IN FLACONE HDPE
Product Name: CORMETO
Product Code: [CORMETO]
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: metirapone
Current Sponsor
Sponsors
AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Run-in Inclusion criteria for run-in phase: - age >18 years and 5 mm at CT scan - SCS (absence of catabolic signs of Cushing’s syndrome) associated with at least one of the following conditions: o Cortisol after 1 mg dexamethasone suppression test >50 nmol/L and baseline ACTH 50 nmol/L and high salivary cortisol at 11 p.m. o Cortisol after 1 mg dexamethasone suppression test >138 nmol/L - Arterial hypertension (blood pressure =140/90 mmHg and/or current treatment with antihypertensive drugs) - Patients who are not candidate for adrenalectomy - Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Exclusion criteria: - Body mass index =40 kg/m2 - Pregnancy or breastfeeding - Women in childbearing age who do not use barrier contraceptives. Barrier contraceptives are: o male or female condom with or without spermicide o cap, diaphragm or sponge with spermicide o a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) - Glucocorticoid treatment during the last year before enrollment - Drugs known to have interactions with Metyrapone - Drug allergy to Metyrapone or drugs belonging to the same class - Patients with severe illness - Patients with primary adrenal insufficiency and severe hypopituitarism - Patients with reduced liver function - Patients with untreated hypothyroidism or taking drugs acting on the hypothalamus-pituitary-adrenal axis - Patients with drug hypersensitivity to Metyrapone or to one of the excipients listed in paragraph 6.1 of the summary of product characteristics (SPCs) – Metyrapone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main aim of the study is to investigate the efficacy of adding Metyrapone to the standard antihypertensive treatment in improving blood pressure control of hypertensive patients with SCS and bilateral adrenal tumors;Secondary Objective: -to identify biomarkers of treatment efficacy and monitoring -to evaluate the adrenal morphology after treatment with Metyrapone;Primary end point(s): The primary endpoint of the study is the reduction of the number and/or the dose of antihypertensive drugs after 12 months of treatment with Metyrapone, while keeping blood pressure within pre-fixed target range (>100/60 mmHg e <130/85 mmHg);Timepoint(s) of evaluation of this end point: 12 moths | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Italy
Contacts
Public ContactU.O. Endocrinologia
AOU di Bologna
Outcome results
None listed