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

NCT05257148 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 283

Last updated 2024-09-20

Study results available
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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

Conditions

Interventions

DRUG

Zofenopril 30 mg

Film-Coated tablets administered as one single dose to be taken in the morning (from 6 am to 10 am) with no restriction on food intake

DRUG

Nebivolol 5 mg

Tablet administered as one single dose to be taken in the morning (from 6 am to 10 am) with no restriction on food intake

DRUG

Zofenopril 30 mg + Nebivolol 5 mg

Both Film coated tablets of Zofenopril 30 mg and Nebivolol 5 mg Tablets will be taken in the morning (from 6 am to 10 am) with no restriction on food intake

Sponsors & Collaborators

  • Menarini International Operations Luxembourg SA

    lead INDUSTRY

Principal Investigators

  • Massimo Volpe, Professor · University "Sapienza" Rome

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2021-12-22
Completion
2021-12-22

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257148 on ClinicalTrials.gov