aprepitant for Obstructive sleep apnea syndrome | Essential (arterial) hypertension

Inclusion criteria

• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Patient's agreement to replace diuretics with another neutral antihypertensive treatment (which does not interfere with the reninangiotensin system) before taking the experimental treatment and throughout the study (if applicable)"}
• {"criterion_text":"- Regulatory Criteria: o Adult aged 18 to 75 / 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"}

Exclusion criteria

• {"criterion_text":"- Minor subject or subject over 75 years old"}
• {"criterion_text":"- 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 < 60 mL/min/1.73m2 for more than 3 months) or moderate hepatic failure defined by ALT and/or AST transaminases > 3N) / o Epilepsy o Known acute infections related to HIV, HBV or HCV / o Active cancer undergoing treatment or immunosuppressive treatments"}
• {"criterion_text":"- 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, glucosegalactose 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."}
• {"criterion_text":"- Placebo contraindication criteria: Lactose intolerance"}

Primary endpoints

• {"endpoint_text":"- 24-hour aldosteronuria measurements. At the beginning and end of each treatment period.","definition_or_measurement_approach":"24-hour urinary aldosterone (aldosteronuria) measured at the beginning and end of each treatment period."}

Secondary endpoints

• {"endpoint_text":"- blood pressure measurements, aldosteronemia, reninemia, plasma and urinary electrolytes, 24-hour plasma and urinary cortisol, plasma ACTH. At the beginning and end of each treatment period.","definition_or_measurement_approach":"Blood pressure by ambulatory blood pressure monitoring (MAPA) with nocturnal analysis; laboratory assays for aldosteronemia, reninemia, plasma and urinary electrolytes, 24-hour plasma and urinary cortisol, and plasma ACTH measured at the beginning and end of each treatment period. Collection of adverse events/serious events for tolerance evaluation."}

France

Earliest CTIS Part Ii Submission Date

27-05-2024

Latest Decision Or Authorization Date

18-03-2026

Processing Time Days

660

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Centre Hospitalier Universitaire Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France