Clinical trial to assess efficacy and safety of the combination of Zofenopril calcium and amlodipine in grade 1-2 hypertensive patients versus each single drug therapy

Phase 1

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

• Registration Number: EUCTR2021-000745-40-IT
• Lead Sponsor: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-21
• Study Completion: 2022-04-28
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 277

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)
•Bilateral tubal occlusion
•Vasectomized partner (performed at least 2 months before screening) (if partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success)
6.A male patient must agree to use contraception during the whole study period and for at least 1 week after the last dose of study treatment and refrain from donating sperms during this period

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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
10.Patients with second- or third-degree heart block (without a pacemaker)
11.Participation in any other interventional drug trial or exposure to other investigational agents within 30 days before Screening (Visit 1)
12.Inability to cooperate or any condition that, in the opinion of the Investigator, could increase the patient’s risk of participating in the study or confound the outcome of the study
13.Patients with conditions that, in the opinion of the Investigator, would prevent a careful adherence to the protocol
14.Patients with severe hypotension
15.Patients who suffer from shock (including cardiogenic shock)
16.Patients treated with Amlodipine 10 mg and Zofenopril (>30 mg or < 30 mg)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified