E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic patient (diabetes mellitus) with hypertension associated with low renin |
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E.1.1.1 | Medical condition in easily understood language |
Diabetic patient with hypertension |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10052741 |
E.1.2 | Term | Endocrine and metabolic secondary hypertension |
E.1.2 | System Organ Class | 100000004866 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012601 |
E.1.2 | Term | Diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluation of Plasma aldosterone variation in the aprepitant sequence versus placebo sequence at the end of each therapeutic sequence. |
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E.2.2 | Secondary objectives of the trial |
(i)Plasma cortisol, (ii) plasma renin, (iii) plasma electrolytes, (iv) HOMA index variations at the end of the aprepitant sequence versus placebo sequence. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or menopausal female subjects; • Age ranging 18-30 years old; • Submitted to a social security regimen; • Agreeing to the study & Informed consent form signed; • Body mass index ([weight (kg)/height (m)]²) < 27; • No treatment received 6 weeks before inclusion; • No anomaly after: complete clinical examination, pulse and blood pressure measurement, ECG; • No biological abnormality after the following biological testing: • Hematology: white & red blood cells & platelets count, haemoglobin, hematocrit, • Blood biochemistry: sodium, potassium, chloride, bicarbonate, creatinine, urea, • Urinary biochemistry (24 h collection): cortisol, aldosterone, • Serologies: HIV, HBV, HCV, • No participation in a clinical trial 3 months ago before inclusion, • Subscription to national social security, • Signed informed consent.
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E.4 | Principal exclusion criteria |
• Female subject potentially pregnant, • Subject younger than 18 year-old and older than 70 year-old, • Subject without diabetes condition or with diabetes but normal blood pressure (below 130/80 mmHg), • Subject with glycated hemoglobin HbA1c < 6.5% or >11%, • Subject with leuconeutropenia (neutrophils below 1700/mm3), • Subject with severe medical or surgical history, • Patients treated with drugs metabolized by CYP3A4 and CYP2C9: corticosteroids, vitamin K , hormonal contraceptives, tolbutamide, benzodiazepines, derived from ergot, antiepileptics, hypericum, macrolides, azole antifungals. • Patients treated with drugs interfering with the renin-angiotensin- aldosterone system : beta-blockers, diuretics , anti -aldosterone drugs , direct renin inhibitors , insulin, • type 2 diabetes patients with a vegetative autonomic neuropathy, • Patients with adrenal mass was diagnosed at imaging, • hepatic or renal impairment (defined respectively by secondary clinical and biological manifestations altered hepatocyte functions or estimated glomerular filtration rate less than 60 mL / min / 1.73 m2);nephrotic syndrome (defined by hypoalbuminemia less than 30 g / L associated with proteinuria at 3 grams / 24 hours);edematous syndrome (defined by the presence of edema of the lower limbs), • Orthostatic hypotension (defined by a decrease in systolic blood pressure of 20 mmHg and at least the diastolic blood pressure of 10 mmHg or more), • arrhythmias or cardiac conduction, • heart failure (NYHA class II minimum), • epilepsy, • serious psychiatric condition, • Severe allergic history, hypersensitivity to aprepitant, • People with hereditary problems of fructose intolerance, glucose malabsorption, galactose, or sucrase-isomaltase, • People with lactose intolerance,
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E.5 End points |
E.5.1 | Primary end point(s) |
Plasma aldosterone concentration |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Plasma (i)cortisol, (ii)renin, and (iii)electrolytes measurement in association with (v) HOMA index during orthostatic test during the aprepitant sequence versus placebo sequence. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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the end of the trial a is the last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |