Status:
COMPLETED
Effectiveness and Safety of Combination of Nebivolol and Zofenopril in Hypertensive patIents Versus Each Monotherapy
Lead Sponsor:
Menarini International Operations Luxembourg SA
Conditions:
Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 mon...
Detailed Description
This is a study with 2 periods (a run-in period of 4 weeks and an assessment period of 8 weeks). Grade 1-2 hypertensive patients (blood pressure \[BP\] ranging from ≥140/90 mmHg to ≤179/109 mmHg) on t...
Eligibility Criteria
Inclusion
- 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)
- Patients are able to understand and have freely given written informed consent at Screening
- 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)
- Patient who are able to comply with all study procedures and who are available for the duration of the study
- Ability to take oral medication and willing to adhere to the drug regimen
- 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)
- 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
- 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
- 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
- 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
- Patients with secondary hypertension of any etiology such as renal diseases, pheochromocytoma, or Cushing's syndrome
- 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
- 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)
- History of angioneurotic edema
- Patients with clinically relevant hepatic impairment
- Patients with sick sinus syndrome, including sino-atrial block
- Patients with second- or third-degree heart block (without a pacemaker)
- History of bronchospasm and bronchial asthma
- Patients with bradycardia (heart rate \<60 bpm)
- Patient with metabolic acidosis
- Patients with severe peripheral circulatory disturbances
- Participation in another study within the last 4 weeks
- Patients with diseases that, in the opinion of the Investigator, prevent a careful adherence to the protocol
- Pregnant and breastfeeding women. A pregnancy test will be performed on all women of childbearing potential at each study visit
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2021
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT05257148
Start Date
May 26 2021
End Date
December 22 2021
Last Update
September 20 2024
Active Locations (1)
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1
Istituto Clinico Humanitas
Milan, Italy, 20089