EUCTR2019-004956-12-IT进行中（未招募）1 期
Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients with Cortisol-Secreting Adrenal Adenomas or Hyperplasia (GRADIENT): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant - GRADIENT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To enroll in this study, each patient Each patient must meet the following key inclusion criteria:
- •1. Male or female, 18 to 80 years of age, inclusive.
- •2. Lack of cortisol suppression (>1.8 µg/dL serum cortisol with adequate dexamethasone levels) on either 1-mg overnight or 2-mg 48-hour DST during Screening.
- •3. Suppressed or low (=15 pg/mL) early-morning ACTH levels on at least
- •2 occasions during Screening.
- •4. A radiologically confirmed adrenal lesion (single adenoma, multiple adenomas, hyperplasia [=3 times the size of the normal adrenal gland]).
- •5. Has at least 1 of the following at Baseline:
- •DM (fasting plasma glucose greater than or equal to126 mg/dL and/or 2-hour oGTT plasma glucose greater than or equal to 200 mg/dL at 2 hours, or HbA1c greater than or equal to 6.5%), or IGT (plasma glucose greater than or equal to140 mg/dL and <200 mg/dL on a 2-hour oGTT).
- •Systolic hypertension (mean SBP greater than or equal to 130 to greater than or equal to 170 mm Hg) based on 24-
- •6. If receiving medical treatment for DM/IGT or hypertension, they have been on a stable dose for at least 4 weeks prior to first dose of study medication.
- •7. For women of childbearing potential, has a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Patients who meet any of the following criteria will not be permitted entry to the study:
- •1. Has severe, uncontrolled hypertension (mean SBP >170 mm Hg or mean DBP >110 mm Hg at Screening), based on 24-hour ABPM.
- •2. Has poorly controlled DM (HbA1c >12% at Screening).
- •3. Has abnormal liver test results (total bilirubin >1.5×ULN or elevated alanine aminotransferase or aspartate aminotransferase >3×ULN at Baseline).
- •4. Has severe renal insufficiency (glomerular filtration rate greater than or equal to 29 mL/min at Baseline).
- •5. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
- •6. Has prolonged QT interval corrected for heart rate using Fridericia's equation (QTcF) (>450 ms for men and >470 ms for women) with normal QRS interval (<120 ms) or QTcF interval >500 ms with wide QRS interval (greater than or equal to 120 ms).
- •7. Has persistent atrial fibrillation.
- •8. Has used or plans to use any treatments for Cushing syndrome within
- •12 weeks prior to Screening and throughout the study, including mifepristone, metyrapone, ketoconazole, fluconazole, or any investigational drug for treatment of Cushing syndrome
- •9. Has adrenocortical carcinoma.
- •10. Has pseudo-Cushing syndrome. Patients with known or suspected pseudo-Cushing syndrome based on medical history (such as patients with severe obesity, major depression, or a history of alcoholism) should undergo a dexamethasone-CRH/DDAVP stimulation test to rule-in or
- •rule-out this possibility.
- •11. Has autonomous cosecretion of aldosterone.
- •12. Has plans for adrenalectomy or nodulectomy during the study, including follow-up.
- •13. Has taken any non-Cushing syndrome investigational drug within 4 weeks prior to Baseline, or within less than 5 times the drug's half-life, whichever is longer.
- •14. Ongoing use of antidiabetic, antihypertensive, antidepressant or lipid-lowering medications that are highly dependent on CYP3A for clearance and that cannot undergo dose modification upon coadministration with strong CYP3A inhibitors.
- •15. Ongoing use of any strong CYP3A inhibitor/inducer or any other prohibited medications.
- •16. Is pregnant or lactating.
- •17. Is a female patient of childbearing potential who cannot use a highly effective method of contraception (including all women <50 years old, women whose surgical sterilization was performed <6 months ago, and women who have had a menstrual period in the last 2 years).
- •18. Has an acute or unstable medical problem that could be aggravated by treatment with the investigational study drug.
- •19. Has a history of severe reaction to the study drug, to a similar class of drug, or to the study drug's excipient.
- •20. In the Investigator's opinion, should not participate in the study or may not be capable of following the study schedule.
- •21. Taking medication for treatment of HIV, hepatitis B, or hepatitis C
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