Effectiveness and Safety of Combination of Nebivolol and Zofenopril in Hypertensive patIents Versus Each Monotherapy

• Status: Completed
• Trial end date: 2021-12-21
• Target enrollment: 0
• Participant gender: All

Summary

Open-label, 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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menarini International Operations Luxembourg SA
• Treatments: Captopril; Nebivolol; Zofenopril

Criteria

Inclusion Criteria:

1. Male or female Caucasian uncontrolled hypertensive patients (see definition in criterion 3) ≥18 and <65 years of age, in monotherapy either with ACE-i or BBs since at least 1 month, at Screening (Visit 1)

2. Patients are able to understand and have freely given written informed consent at Screening

3. Patients with mean sitting Systolic Blood Pressure ≥140 mmHg and ≤179 mmHg and/or mean sitting Diastolic Blood Pressure ≥ 90 mmHg and ≤109 mmHg at Screening (Visit 1)

4. Patient 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: a Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) b Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) c Intrauterine device (IUD) d Intrauterine hormone-releasing system (IUS) e Bilateral tubal occlusion f 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.

Exclusion Criteria:

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 NEB and ZOF

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. A pregnancy test will be performed on all women of childbearing potential at each study visit