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PILOT STUDY OF THE EFFECT OF A SUBSTANCE P ANTAGONIST, APREPITANT, ON THE SECRETION OF ALDOSTERONE IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA AND ARTERIAL HYPERTENSION SYNDROME - (APHOS3)
EU CTIS ID: 2024-514837-39-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
- 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)
- 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)
- 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
You likely can't join if
- Minor subject or subject over 75 years old
- 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
- 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.
- Placebo contraindication criteria: Lactose intolerance
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.