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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021988-32-IT

Enrollment

324

Registered

2010-12-17

Start date

2010-09-27

Completion date

Unknown

Last updated

2013-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

elderly subjects (age > 65 years) affected by Isolated Systolic Hypertension MedDRA version: 9.1 Level: LLT Classification code 10050591

Interventions

Trade Name: BIFRIZIDE Pharmaceutical Form: Capsule, hard INN or Proposed INN: IDROCLOROTIAZIDE CAS Number: 58-93-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Subject with a sitting DBP = 90 mmHg and/or a sitting SBP 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 g/die, oral and parenteral corticoids, antiacid agents, potassium substitutes, class I and III antiarrhythmic agents, cardiac glycosides;

Design outcomes

Primary

Measure	Time frame
Main Objective: • To compare the antihypertensive efficacy of Zofenopril 30 mg plus HCTZ 12.5 mg versus Irbersartan 150 mg plus HCTZ 12.5 mg by assessment of the average reduction in mean day-time Systolic Blood Pressure (SBP) from baseline in the two groups after 6 weeks of treatment.;Secondary Objective: To compare the antihypertensive efficacy in the two treatment groups by assessment of: average reduction in mean day-time Systolic Blood Pressure (SBP) in the two groups after 12 and 18 weeks; the rate of subjects with day-time normalization rate after 6,12 and 18; the rate of subjects with office normalization rate after 6, 12 and 18 weeks; the rate of subjects with day-time responder rate after 6, 12 and 18 weeks; the rate of subjects with office responder rate after 6, 12 and 18 weeks; the average reduction in sitting office Systolic Blood Pressure and Diastolic Blood Pressure after 6, 12 and 18 weeks; the average changes in microalbuminuria and/or in albumine-creatinine ratio from baseline in the two groups and average changes in estimated creatinine clearance (Cockroft-Gault formula) from baseline in the two groups after 18 weeks of treatment; the average changes in cardiovascular risk from baseline in the two groups after 6, 12 and 18 weeks of treatment by mean of Heart Sco;Primary end point(s): 24-h Blood Pressure monitoring: average reduction of mean day-time Systolic Blood Pressure (SBP) from baseline to the end of the first step of treatment (6 weeks) in the two groups	—

Measure

Time frame

Main Objective: • To compare the antihypertensive efficacy of Zofenopril 30 mg plus HCTZ 12.5 mg versus Irbersartan 150 mg plus HCTZ 12.5 mg by assessment of the average reduction in mean day-time Systolic Blood Pressure (SBP) from baseline in the two groups after 6 weeks of treatment.;Secondary Objective: To compare the antihypertensive efficacy in the two treatment groups by assessment of: average reduction in mean day-time Systolic Blood Pressure (SBP) in the two groups after 12 and 18 weeks; the rate of subjects with day-time normalization rate after 6,12 and 18; the rate of subjects with office normalization rate after 6, 12 and 18 weeks; the rate of subjects with day-time responder rate after 6, 12 and 18 weeks; the rate of subjects with office responder rate after 6, 12 and 18 weeks; the average reduction in sitting office Systolic Blood Pressure and Diastolic Blood Pressure after 6, 12 and 18 weeks; the average changes in microalbuminuria and/or in albumine-creatinine ratio from baseline in the two groups and average changes in estimated creatinine clearance (Cockroft-Gault formula) from baseline in the two groups after 18 weeks of treatment; the average changes in cardiovascular risk from baseline in the two groups after 6, 12 and 18 weeks of treatment by mean of Heart Sco;Primary end point(s): 24-h Blood Pressure monitoring: average reduction of mean day-time Systolic Blood Pressure (SBP) from baseline to the end of the first step of treatment (6 weeks) in the two groups

—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026