A multicentre, multinational, randomised, double-blind, pilot, ascending dose for non responder, parallel group study on the therapeutic efficacy and safety of o.d. Zofenopril 30 mg plus HCTZ 12.5 mg vs. Irbersartan 150 mg plus HCTZ 12.5 mg in elderly subjects (age > 65 years) affected by Isolated Systolic Hypertension never treated or non responder to previous antihypertensive therapy (monotherapy or association of maximum two treatments) - LUMI/10/ZOF- HYP/001

• Conditions: elderly subjects (age > 65 years) affected by Isolated Systolic Hypertension; MedDRA version: 9.1Level: LLTClassification code 10050591

• Registration Number: EUCTR2010-021988-32-IT
• Lead Sponsor: SOFARMACO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-17
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

•Male or female subjects aged >65 years;
•Subjects willing and able to give written informed consent;
•Subjects having at baseline a sitting DBP < 90 mmHg and a sitting SBP = 140 mmHg (value of office measurement) and a mean day-time DBP < 85 mmHg and a mean day-time SBP = 135 mmHg (value of ambulatory blood pressure monitoring, i.e. ABPM);
•Previously untreated subjects or subjects who stopped their antihypertensive treatments since at least 6 months or subjects who are on treatment with mono- or combination therapies, of no more that two drugs that cannot be Zofenopril, Irbersartan, Zofenopril associated with diuretics, Irbersartan associated with diuretics. who satisfy the blood pressure level criteria for inclusion despite previous/concomitant treatment with another antihypertensive drug;
•Body mass index < 30 kg/m2;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Subject with a sitting DBP = 90 mmHg and/or a sitting SBP < 140 mmHg at baseline (value of office measurement);
•Subject with mean day-time DBP = 85 mmHg and/or a mean day-time SBP < 135 mmHg;
•Subjects with a sitting SBP = 200 mmHg at baseline;
•Subject with secondary or malignant hypertension;
•Myocardial infarction or cerebrovascular disorders within the last 6 months;
•Subjects who underwent coronary angioplasty within 6 months prior to enrolment in the study or subjects who will undergo coronary angioplasty within 6 months after study entry;
•History or current evidence of severe heart failure (NYHA=3);
•Haemodinamic relevant rhythm disturbances (including atrial flutter or atrial fibrillation with ventricular response, frequent ectopic beats, bradycardia (? 55 bpm), evidence of AV-block on ECG of more than 1st degree, serious arrhythmia);
•Arm circumference <24 or >32 cm;
•History of angioneurotic edema;
•Clinically significant or unstable concurrent disease: uncontrolled diabetes, uncontrolled hypothyroidism, significant renal impairment (serum creatinine = 2.0 mg/dl), significant hepatic impairment (AST or ALT twice the upper limit of the normal range), poorly controlled respiratory, gastro-intestinal, neurological or haematological disease, autoimmune disease, serum electrolytes disorders (e.g. hyperkalemia);
•Subjects affected from neutropenia (WBC < 3,500/mm3) and or anaemia (RBC < 3,500,000 mm3);
•Participation in any investigational drug study in the 3 months before the start of the study;
•History of alcohol or drug abuse;
•Allergy, sensitivity or intolerance to study drugs and/or study drugs excipients;
•Previous antihypertensive treatments with Zofenopril, Irbersartan, Zofenopril associated with diuretics, Irbersartan associated with diuretics;
•Concomitant treatment, from V0 onwards, with other drugs that affect blood pressure (i.e. others ACE-inhibitors and/or diuretics, angiotensin II receptor antagonists, calcium antagonists, alfa- and beta-blockers, long-acting nitrates, MAO inhibitors, clonidine);
•Concomitant therapy with lithium, neuroleptics (i.e. haloperidol), indometacin, NSAIDs, acetylsalicylic acid > 3 g/die, oral and parenteral corticoids, antiacid agents, potassium substitutes, class I and III antiarrhythmic agents, cardiac glycosides;

Study & Design

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