Perindopril Amlodipine Regimen versus AT1-Receptor Blocker/thiazide: a comparison of Blood pressure Lowering: Efficacy and Safety. A randomised, double blind, 9 month study of the efficacy and safety of four uptitrated doses of oral fixed combinations of perindopril/amlodipine, including a comparison with uptitrated doses of oral fixed combination of irbesartan and hydrochlorthiazide in mild to moderate hypertension.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005799-42-IE

Enrollment

3000

Registered

2007-09-13

Start date

2007-11-23

Completion date

Unknown

Last updated

2014-05-12

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

Conditions

Essential arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10020775 Term: Hypertension arterial

Interventions

Product Name: S05985 Product Code: S05985 Pharmaceutical Form: Tablet INN or Proposed INN: Perindopril arginine Current Sponsor code: S09490 Concentration unit: mg milligram(s) Concentration type: equ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Outpatients, - Men or women, - 18 years old at least, - Mild to moderate hypertensive patient. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pregnant or breastfeeding women, - Secondary hypertension, - Any patient suffering from an acute or chronic illness.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To assess the efficacy of each dose increase of perindopril/amlodipine combination on blood pressure normalisation during a 6-month period. - To assess the safety of the perindopril/amlodipine combination for the 9 month duration of the trial, (minimum of 6 month exposure for the highest dose).;Secondary Objective: To compare perindopril/amlodipine combination strategy versus irbesartan/hydrochlorothiazide combination strategy changes in blood pressure parameters after 6 months;Primary end point(s): Proportion of participants with controlled blood pressure	—

Measure

Time frame

Main Objective: - To assess the efficacy of each dose increase of perindopril/amlodipine combination on blood pressure normalisation during a 6-month period. - To assess the safety of the perindopril/amlodipine combination for the 9 month duration of the trial, (minimum of 6 month exposure for the highest dose).;Secondary Objective: To compare perindopril/amlodipine combination strategy versus irbesartan/hydrochlorothiazide combination strategy changes in blood pressure parameters after 6 months;Primary end point(s): Proportion of participants with controlled blood pressure

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Countries

Ireland, Netherlands, United Kingdom

Outcome results

None listed

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