Interventional clinical trial to assess efficacy and safety of the extemporaneous combination of Zofenopril calcium and amlodipine in grade 1-2 hypertensive patients versus each monotherapy - MASOLINO Study

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA0 sites277 target enrollmentSeptember 21, 2021

ConditionsGrade 1-2 hypertension MedDRA version: 20.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

DrugsZOPRANOL - 28 COMPRESSE RIVESTITE CON FILM 30 MG IN BLISTER (PVDC/PVC/AL)AMLODIPINA EUROGENERICI - 5 MG COMPRESSE 14 COMPRESSE IN BLISTER AL/PVC/PE/PVDC AMLODIPINA EUROGENERICI - 10 MG COMPRESSE 14 COMPRESSE IN BLISTER AL/PVC/PE/PVDC

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Grade 1-2 hypertension
Sponsor: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA
Enrollment: 277
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 21, 2021

End Date

April 28, 2022

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA

Eligibility Criteria

Inclusion Criteria

•A patient will be considered eligible for inclusion in the study only if all the following criteria are met:
•1\.Male or female Grade 1\-2hypertensive patients: with mean sitting SBP \=140 mmHg and \=179 mmHg and/or mean sitting DBP \= 90 mmHg and \=109 mmHg at Screening, with \=18 and \=65 years of age, in monotherapy either with ZOF 30 mg or AML 5 mg, orany other ACE\-I or CCBs (Felodipine, isradipine, lacidipine, lercanidipine, nicardipine, nifedipine, and nisoldipine) for at least 1 months before Visit 1 (Screening).
•2\.Patients who are able to understand and give written informed consent at Screening
•3\.Patients who are available for the entire trial period and willing to adhere to the protocol requirements
•4\.Ability to take oral medication and willing to adhere to the drug regimen
•5\.Female patients are eligible to participate if not pregnant, or not breastfeeding and must refrain from donating or storing eggs. For females of reproductive potential: use of highly effective contraception (e.g., 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) such as:
•Combined (estrogen\- and progestogen\-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
•Progestogen\-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
•Intrauterine device (IUD)
•Intrauterine hormone\-releasing system (IUS)

Exclusion Criteria

•Any patient who meets any of the following criteria will not qualify for entry into the study:
•1\.Known contraindications, presence of not recommended / contraindicated concomitant therapy allergies, or significant history of hypersensitivity to zofenopril, amlodipine, other ACE\-inhibitors or dihydropyridines calcium channel blockers, or any related products (including excipients of the formulations as outlined in the Investigator’s Brochure \[IB]) or), summary of product characteristics (SmPCs) or local package inserts for AML and ZOF
•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, haematological, 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, valve replacement (transcatheter aortic valve implantation, MitraClip), cerebrovascular accident (stroke, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke), or transient ischemic attack. Patients with who have undergone other surgery that in the in the opinion of the Investigator may limit the ability to evaluate the efficacy or safety of the tested medications.
•4\.Patients with secondary hypertension of any aetiology such as renal diseases, pheochromocytoma, Cushing’s syndrome hyperaldosteronism, renovascular disease, thyroid disorders
•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\.Patients with history of angioneurotic oedema
•8\.Patients with clinically relevant hepatic impairment
•9\.Patients with sick sinus syndrome, including sino\-atrial block