drugset / Trial / NCT05279807

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

NCT05279807

Phase 4 Completed 277 enrolled Menarini International Operations Luxembourg SA
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amlodipine Other / unclassified 5 mg Oral
Comparator Amlodipine Other / unclassified 10 mg Oral
Comparator Zofenopril Small molecule 30 mg Oral

Indications