Patients with obstructive sleep apnea syndrome with arterial hypertension MedDRA version: 20.0 Level: HLT Classification code 10052741 Term: Endocrine and metabolic secondary hypertension System Organ Class: 100000004866
Conditions
Interventions
Trade Name: EMEND
Product Name: EMEND
Product Code: A04AD12
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
DRCI - CHU de Rouen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject with severe obstructive sleep apnea syndrome defined by an apnea and hypopnea index (AHI) = 30/h in polysomnography or ventilatory polygraphy (requiring continuous positive pressure equipment). 2. Subject with essential hypertension treated medically or by lifestyle and dietary measures or newly diagnosed (defined by SBP = 140 and/or PAD = 90 mmHg according to current SFHTA-HAS recommendations). 3. Patient's agreement to replace diuretics with another neutral antihypertensive treatment (which does not interfere with the renin-angiotensin system) before taking the experimental treatment and throughout the study (if applicable) 4. Regulatory Criteria: o Adult aged 18 to 85 o Affiliation to a social security scheme o Person who has read and understood the information letter and signed the consent form o For women: - of childbearing age, need for effective mechanical contraception (condoms) during the study and within 2 months of the last month taken, with a negative urine pregnancy test on inclusion and for the duration of the study study at V2 and V4, - postmenopausal: amenorrhea not medically induced for at least 12 months before the V1 visit 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Minor subject or subject over 85 years old 2. Criteria relating to associated pathologies leading to particular risks: o Subject with excessive daytime sleepiness with a contraindication to driving (Epworth score > 16) o Severe uncontrolled cardiovascular disease: myocardial infarction or stroke in the last 6 months, unstable angina, heart failure. o Knowledge of chronic renal failure defined by a glomerular filtration rate 3N) o Epilepsy o Known acute infections related to HIV, HBV or HCV o Active cancer undergoing treatment or immunosuppressive treatments 3. Criteria for aprepitant: o Hypersensitivity to the active substance (aprepitant) or/and one of the excipients (contents and capsule shell) o People with hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase/isomaltase deficiency o Subject treated with drugs metabolized by cytochromes CYP3A4 and CYP2C9: corticosteroids (dexamethason, methylprednisolone), anti vitamin K (warfarin, acenocoumarol), benzodiazepines (midazolam, alprazolam, triazolam), anti-depressants (nefazodone), quinidine, hormonal contraceptives , ergot alkaloids (ergotamine, diergotamine), immunosuppressants (ciclosporin, tacrolimus, sirolimus, everolimus), morphine (alfentanil, fentanyl), antibiotics (rifampicin and clarithromycin-type macrolides, telithromycin), azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole), anti-virals (protease inhibitors), anti-epileptics (phenytoin, carbamazepine, phenobarbital), chemotherapies (etoposide, vinorelbine, ifosfamide, irinotecan), diuretics (tolbutamide) and herbal preparations containing St. John's wort. As well as these molecules in co-administration pimozide, terfenadine, astemizole and cisapride. 4. Placebo contraindication criteria: Lactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this work is to evaluate the effect of the administration of an NK1 receptor antagonist (aprepitant) on aldosterone secretion in patients with obstructive sleep apnea syndrome (OSAS) and of arterial hypertension. ;Secondary Objective: The secondary objectives of this work will be to evaluate the effects of the administration of an antagonist of the NK1 receptor (aprepitant) on blood pressure, renin secretion, plasma and urinary electrolytes, cortisol and ACTH, as well as the tolerance of treatment in patients with obstructive sleep apnea syndrome and arterial hypertension. ;Primary end point(s): Primary Endpoint: 24-hour aldosteronuria measurements.;Timepoint(s) of evaluation of this end point: At the beginning and end of each treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: blood pressure measurements, aldosteronemia, reninemia, plasma and urinary electrolytes, 24-hour plasma and urinary cortisol, plasma ACTH. ;Timepoint(s) of evaluation of this end point: At the beginning and end of each treatment period. | — |
Countries
France
Contacts
Public ContactDavid MALLET
DRCI - CHU de Rouen
Outcome results
None listed