[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577665":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":85,"collaborators":26,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":26,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":26,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":26,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","Metirapone in addition to standardized antihypertensive therapy, as provided in the normal course of care and in accordance with current European guidelines. Metirapone will be provided in 250-mg capsules, in the form of commercially available packs. In Group A, patients will receive Metirapone at the initial dosage of 250 mg, 1 capsule per day. Dosage may be adjusted according to clinical response and tolerability, up to a maximum of 750 mg (3 capsules per day). The drug should be taken after a meal. The drug should be stored at room temperature. The expected duration of study treatment is 12 months, after which patients will discontinue Metirapone and continue with therapies as per the normal course of care.",[13],"Drug: Metarapone",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B","ACTIVE_COMPARATOR","Standardized antihypertensive therapy, as provided in the normal course of care and in accordance with current European guidelines.",[19],"Drug: Standardized antihypertensive therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Metarapone","Metirapone is an inhibitor of the enzyme 11-β-adrenal hydroxylase, which is deputed to catalyze the conversion of 11-desoxycortisol (11-S) to cortisol and 11-deoxycorticosterone (DOC) to corticosterone.",[9],null,{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":26},"Standardized antihypertensive therapy",[15],[31],{"name":32,"affiliation":5,"role":33},"Guido Di Dalmazi, MD","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":26,"email":38},"CONTACT","+390512143009","guido.didalmazi@unibo.it",[40,55,70],{"facility":5,"status":41,"city":42,"state":26,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Bologna","40138","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],11.33875,44.49381,{"lat":50,"lon":49},[53,54],{"name":32,"role":36,"phone":37,"phoneExt":26,"email":38},{"name":32,"role":33,"phone":26,"phoneExt":26,"email":26},{"facility":56,"status":41,"city":57,"state":26,"zip":58,"country":44,"countryCode":45,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Azienda Ospedaliera Universitaria Federico II","Naples","80131",{"type":47,"coordinates":60},[61,62],14.26811,40.85216,{"lat":62,"lon":61},[65,69],{"name":66,"role":36,"phone":67,"phoneExt":26,"email":68},"Chiara Simeoli, MD","+390817462510","chiara.simeoli@unina.it",{"name":66,"role":33,"phone":26,"phoneExt":26,"email":26},{"facility":71,"status":41,"city":72,"state":26,"zip":73,"country":44,"countryCode":45,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Azienda Ospedale-Università Padova","Padova","35128",{"type":47,"coordinates":75},[76,77],11.14261,44.38225,{"lat":77,"lon":76},[80,84],{"name":81,"role":36,"phone":82,"phoneExt":26,"email":83},"Mattia Barbot, MD","+390498213000","mattia.barbot@unipd.it",{"name":81,"role":33,"phone":26,"phoneExt":26,"email":26},{"type":86,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100577665","phase-4-effect-of-metyrapone-on-cardiovascular-risk-factors-in-patients-with-adrenal-incidentalomas-and-cushings-syndrome-100577665",false,"NCT06801249","Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Cushing's Syndrome","\"Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Subclinical\u002FMild Cushing's Syndrome","Inclusion Criteria:\n\nInclusion criteria - run-in (phase 1)\n\n* Unilateral or bilateral adrenal nodules with benign features associated with thickening of the adrenal arms \\>5 mm on abdominal CT scan\n* SCS (detected 2 times in the 6 months before run-in) defined by the absence of catabolic signs of Cushing's syndrome in association with any of these 3 conditions:\n\n  * Cortisol levels after dexamethasone 1 mg test \\>50 nmol\u002FL associated with baseline ACTH \\\u003C10 pg\u002FmL\n  * Cortisol levels after dexamethasone 1 mg test \\>50 nmol\u002FL associated with increased nocturnal (11 pm) salivary cortisol\n  * Cortisol levels after dexamethasone 1 mg test \\>138 nmol\u002FL\n* Hypertension (BP ≥140\u002F90 mmHg and\u002For ongoing antihypertensive treatment)\n* Patients who cannot undergo surgery\n* Acquisition of informed consent.\n\nInclusion criteria - randomization (phase 2)\n\n\\- BP \\>100\u002F60 mmHg and \\\u003C130\u002F85 mmHg on antihypertensive therapy (lowest effective dose) within 6-10 months after enrollment.\n\nExclusion Criteria:\n\n* Body mass index ≥40 kg\u002Fm2\n* Pregnant or lactating women; diagnosis of pregnancy will be made by serum β-HCG assay\n* Women of childbearing age using contraceptive measures other than barrier contraception. Barrier contraceptive measures are: o Male or female condom with or without spermicide o Cervical cup, diaphragm or sponges with spermicide o Combination of male condom and cervical cup, diaphragm or sponges with spermicide (dual barrier methods)\n* Treatment with steroids in the last year before enrollment\n* Taking medications known to interfere with Metirapone\n* Known or suspected hypersensitivity to the drug or drug class under study\n* Patients with serious clinical conditions that, in the opinion of the Investigator, contraindicate the patient's participation in the study\n* Patients with primary corticosurrenal insufficiency, impaired adrenal secretion, and severe hypopituitarism\n* Patients with impaired liver function\n* Patients with untreated hypothyroidism or being treated with drugs that have an action on the hypothalamic-pituitary-adrenal axis\n* Patients with hypersensitivity to the active ingredient or any of the excipients listed in section 6.1 of the RCP - Metirapone.","ALL","18 Years","75 Years",{"count":98,"type":99},50,"ESTIMATED","INTERVENTIONAL",[102],"PHASE4","Drug interventional, controlled, randomized open-label, parallel-group, multicenter study in patients with bilateral adrenal incidentalomas associated with subclinical Cushing's syndrome",[105,106],"Adrenal Incidentalomas","Cushing Syndrome","2025-01-24",{"date":109,"type":110},"2025-01-30","ACTUAL",{"date":112,"type":110},"2021-02-23",{"date":114,"type":99},"2025-02-17",{"name":5,"class":6},3]