Diabetic patient (diabetes mellitus) with hypertension associated with low renin MedDRA version: 18.1 Level: HLT Classification code 10052741 Term: Endocrine and metabolic secondary hypertension System Organ Class: 100000004866 MedDRA version: 18.1 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: EMEND
Product Name: EMEND
Pharmaceutical Form: Capsule
INN or Proposed INN: APREPITANT
Other descriptive name: APREPITANT
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Rouen University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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) =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
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 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of Plasma aldosterone variation in the aprepitant sequence versus placebo sequence at the end of each therapeutic sequence.;Secondary Objective: (i)Plasma cortisol, (ii) plasma renin, (iii) plasma electrolytes, (iv) HOMA index variations at the end of the aprepitant sequence versus placebo sequence.;Primary end point(s): Plasma aldosterone concentration ;Timepoint(s) of evaluation of this end point: Day 14 and Day 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: Day 14 and Day 48 | — |
Countries
France
Contacts
Public ContactMAILLARD
Rouen University Hospital
Outcome results
None listed