EUCTR2020-002340-23-IT进行中（未招募）1 期
Open-label, multicenter, multinational, interventional clinical trial to assess effectiveness and safety of the extemporaneous combination of nebivolol and zofenopril calcium in grade 1 to 2 hypertensive patients versus each monotherapy - MASACCIO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female Caucasian uncontrolled hypertensive patients =18 and <65 years of age (see definition in criterion 3), in monotherapy either with ACE-i or BBs since at least 1 month, at Screening.
- •2. Patients are able to understand and have freely given written informed consent at Screening.
- •3. Patients with mean sitting SBP =140 mmHg and =179 mmHg and/or mean sitting DBP = 90 mmHg and =109 mmHg at Screening.
- •4. Patients who are able to comply with all study procedures and who are available for the duration of the study.
- •5. Ability to take oral medication and willing to adhere to the drug regimen.
- •6. A 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 of highly effective contraception (eg, 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 (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- •¿ progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- •¿ intrauterine device (IUD)
- •¿ intrauterine hormone-releasing system (IUS)
- •¿ bilateral tubal occlusion
- •¿ vasectomized partner (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).
- •7. A male patient with female partner 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 sperms 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 216
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known contraindications, allergies, or hypersensitivities to any of the study medications or excipient as outlined in the investigators brochures IBs, summary of product characteristics (SmPCs) or local package inserts for nebivolol and zofenopril calcium.
- •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 within the last 6 months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, bypass surgery, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke), or transient ischemic attack.
- •4. Patients with secondary hypertension of any etiology such as renal diseases, pheochromocytoma, or Cushing’s syndrome.
- •5. Patients with severe heart failure (New York Heart Association classification III-IV), a narrowing of the aortic or bicuspid valve, an obstruction of cardiac outflow (obstructive, hypertrophic cardiomyopathy) or symptomatic coronary disease.
- •6. Patients with clinical evidence of renal disease as per the Investigator’s judgement (including renovascular occlusive disease, nephrectomy and/or renal transplant, bilateral renal artery stenosis or unilateral renal artery stenosis in a solitary kidney, or severe renal impairment).
- •7. History of angioneurotic edema.
- •8. Patients with clinically relevant hepatic impairment.
- •9. Patients with sick sinus syndrome, including sino-atrial block.
- •10. Patients with second- or third-degree heart block (without a pacemaker).
- •11. History of bronchospasm and bronchial asthma.
- •12. Patients with bradycardia (heart rate <60 bpm).
- •13. Patient with metabolic acidosis.
- •14. Patients with severe peripheral circulatory disturbances.
- •15. Participation in another study within the last 4 weeks.
- •16. Patients with diseases that, in the opinion of the Investigator, prevent a careful adherence to the protocol
- •17. Pregnant and breastfeeding women. NOTE: a pregnancy test will be performed on all women of childbearing potential at each study visit.
研究者
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