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Effectiveness and Safety of Combination of Amlodipine and Zofenopril in Hypertensive Patients Versus Each Monotherapy

NCT05279807 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2024-10-21

Study results available
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Summary

Study to assess the anti-hypertensive efficacy and safety of the extemporaneous combination of Zofenopril 30 mg in combination with Amlodipine 5 mg or AML 10 mg in lowering the sitting diastolic BP after 8 weeks of treatment in patients with uncontrolled BP previously treated with Zofenopril or Amlodipine (5 mg) monotherapies for at least 4 weeks.

Conditions

Interventions

DRUG

Zofenopril

Film-Coated tablets administered orally once daily according instructions provided by Principal Investigator.

DRUG

Amlodipine

Tablets of 5mg and 10mg administered orally once daily according instructions provided by Principal Investigator.

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
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-04-28
Completion
2022-04-28

Countries

  • Hungary

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 NCT05279807 on ClinicalTrials.gov