Grade 1 and 2 hypertension MedDRA version: 20.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: LOBIVON - 28 COMPRESSE 5 MG
Product Name: Nebivolol
Product Code: [na]
Pharmaceutical Form: Tablet
INN or Proposed INN: NEBIVOLOLO
CAS Number: 99200-09-6
Current Sponsor code: na
Concentra
Sponsors
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female Caucasian uncontrolled hypertensive patients =18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antihypertensive effect of the extemporaneous combination of nebivolol 5 mg and zofenopril calcium 30 mg in lowering sitting diastolic blood pressure (DBP) after 8 weeks of treatment, in patients with uncontrolled blood pressure (BP) who were previously treated with nebivolol or zofenopril calcium monotherapies for at least 4 weeks;Secondary Objective: To assess the antihypertensive effect of the extemporaneous combination of nebivolol 5 mg and zofenopril calcium 30 mg in lowering sitting systolic blood pressure (SBP) after 8 weeks of treatment in patients with uncontrolled blood pressure after at least 4 weeks of treatment with nebivolol or zofenopril calcium monotherapies To evaluate the total number and percentage of patients who achieved the blood pressure goal (sitting blood pressure =130/80 mmHg) at Visit 2 and Visit 3 To assess compliance to the monotherapy and extemporaneous combination (actual doses taken versus doses to be taken) To evaluate the safety and tolerability of the zofenopril calcium and nebivolol monotherapies, and the extemporaneous combination of nebivolol 5 mg and zofenopril calcium 30 mg after 8 weeks of treatment;Primary end point(s): Change in mean sitting DBP between Week 0 (Visit 2) and Week 8 (Visit 3);Timepoint(s) of evaluation of this end point: Week 0 and Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ¿ Change in mean sitting SBP between Week 0 (Visit 2) and Week 8 (Visit 3) ¿ Total number and proportion of patients achieving the BP goal (sitting BP =130/80 mmHg) at Week 0 (Visit 2) and Week 8 (Visit 3) ¿ Adherence to treatment will be measured through treatment compliance which is 100 × (actual doses taken versus planned doses to be taken) from Visit 1 to Visit 2 for the monotherapies, and from Visit 2 to Visit 3 for the extemporaneous combination ¿ Safety and tolerability of the nebivolol and zofenopril calcium monotherapies, as well as extemporaneous combination between nebivolol 5 mg and zofenopril calcium 30 mg will be measured by Adverse Events (AEs),Serious Adverse Events (SAEs),Adverse Events Of Special Interest (AEOSI), vital signs, physical examination, ECG, and concomitant medications at Week 0 (Visit 2) and Week 8 (Visit 3) ;Timepoint(s) of evaluation of this end point: Week 0 and Week 8 Week 0 and Week 8 Week 0 and Week 8 Week 0 and Week 8 | — |
Countries
Italy, Lithuania, Poland
Contacts
Public ContactClinical Operation Director
Menarini
Outcome results
None listed