EUCTR2022-003060-25-HU进行中（未招募）1 期
Open-label, multicenter, multinational, interventional Clinical Trial to assess Efficacy and Safety of the extemporaneous combination of Nebivolol and Ramipril in hypertensive patients - ARTEMISIA study - ARTEMISIA study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patient will be considered eligible to be enrolled in the study only if he/she meets all the following inclusion criteria:
- •1. Willing to comply with all study activities and procedures for the duration of the study and provided signed, written informed consent prior to any study procedures at Screening Visit.
- •2. Male or female patients =18 and <65 years of age, with hypertension with mean sitting SBP =140 mmHg and =179 mmHg and mean sitting DBP =90 mmHg and =109 mmHg at Visit 1 (screening) while on monotherapy treatment either with BBs (NEB 5 mg or any dose if other BB) or ACE-is (RAM 5 mg or any dose if other ACE-i) for at least 30 days before Visit 1 (screening).
- •3. Ability to take oral medication and willing to adhere to the drug regimen.
- •4. Female patient of childbearing potential is eligible to participate if she is not pregnant, or not breastfeeding. A woman is considered fertile following menarche and until becoming postmenopausal unless permanently sterile. Women of childbearing potential must agree to use highly effective contraception (e.g., method of birth control throughout the study period and for 4 weeks after study completion defined as a method which results in a failure rate of less than 1% per year) and also must refrain from donating or storing eggs during this time. Highly effective contraception methods can be:
- •Combined hormonal contraception (estrogen- and progestogen-containing) associated with inhibition of ovulation (oral, intravaginal, and transdermal).
- •Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, and implantable).
- •Intrauterine device.
- •Intrauterine hormone-releasing system.
- •Bilateral tubal occlusion.
- •Vasectomized partner (procedure conducted at least 2 months before the screening), (provided that partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success).
- •5. A male patient with female sexual partners must agree to use contraception during the whole study period and for at least 1 week after the last dose of study treatment and refrain from donating sperm during this period.
- •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 270
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any patient who meets any of the following criteria will not qualify for entry into the study:
- •1. Patients with documented history of hypersensitivity to NEB, RAM, other BBs or other ACE-is, or any related products (including excipients of the formulations) as outlined in the relevant Investigators Brochures, summary of product characteristics or local package inserts for Nebivolol and Ramipril.
- •2. Patients with serious disorders (in the opinion of the Investigator) which may limit the ability to evaluate the efficacy or safety of the tested medications, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine, or metabolic, hematological, or oncological, neurological, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic patients.
- •3. Patients having a history of the following conditions within the last 6 months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, bypass surgery, heart failure, hypertensive encephalopathy, valve replacement (transcatheter aortic valve implantation, mitraclip), cerebrovascular accident (stroke), or transient ischemic attack.
- •4. Patients with condition of hypotension with SBP <90 mmHg and/or DBP <60 mmHg.
- •5. Acute heart failure (12 months before enrolment), cardiogenic shock, or episodes of heart failure decompensation requiring intravenous inotropic therapy.
- •6. Patients with secondary hypertension of any etiology including renal diseases, Cushing’s syndrome, hyperaldosteronism, renovascular disease and thyroid disorders.
研究者
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