Efficacy and safety of the fixed oral low-dose perindopril arginine 3.5 mg/amlodipine 2.5 mg combination compared with each component (perindopril arginine 3.5 mg and amlodipine 2.5 mg) and with perindopril arginine 5 mg and amlodipine 5 mg. Randomized, double-blind, placebo-controlled study over 8 weeks in hypertensive patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005797-44-LT

Enrollment

1500

Registered

2007-02-06

Start date

2007-03-14

Completion date

Unknown

Last updated

2012-03-19

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: 8.1 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: S09490-6 Concentration unit: mg milligram(s) Concentration type: e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Men or women, - 18 to 80 years old, - Essential uncomplicated mild to moderate hypertensive patients requiring antihypertensive treatment 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: - pregnancy, - obesity, - perindopril resistant hypertension, - amlodipine resistant hypertension, - secondary hypertension.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To demonstrate a statistically significant and clinically relevant greater blood pressure lowering effect with perindopril / amlodipine combination than with placebo. - To demonstrate a statistically significant greater blood pressure lowering effect with perindopril / amlodipine combination than with each of monocomponent perindopril and amlodipine given separately. - To demonstrate that the blood pressure lowering effect of the perindopril /amlodipine fixed low-dose combination is not inferior to those of perindopril and amlodipine given separately.;Secondary Objective: - To demonstrate that the response and normalisation rate on the fixed low-dose combination perindopril / amlodipine exceed that on placebo by an amount that is statistically significant and clinically valuable. - To show a trend towards better response and normalisation rate regarding the low-dose fixed combination perindopril /amlodipine as compared to perindopril and to amlodipine. - To show a trend towards better safety regarding the low-dose fixed combination perindopril /amlodipine as compared to perindopril and to amlodipine.;Primary end point(s): Change in supine diastolic blood pressure	—

Measure

Time frame

Main Objective: - To demonstrate a statistically significant and clinically relevant greater blood pressure lowering effect with perindopril / amlodipine combination than with placebo. - To demonstrate a statistically significant greater blood pressure lowering effect with perindopril / amlodipine combination than with each of monocomponent perindopril and amlodipine given separately. - To demonstrate that the blood pressure lowering effect of the perindopril /amlodipine fixed low-dose combination is not inferior to those of perindopril and amlodipine given separately.;Secondary Objective: - To demonstrate that the response and normalisation rate on the fixed low-dose combination perindopril / amlodipine exceed that on placebo by an amount that is statistically significant and clinically valuable. - To show a trend towards better response and normalisation rate regarding the low-dose fixed combination perindopril /amlodipine as compared to perindopril and to amlodipine. - To show a trend towards better safety regarding the low-dose fixed combination perindopril /amlodipine as compared to perindopril and to amlodipine.;Primary end point(s): Change in supine diastolic blood pressure

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Countries

France, Hungary, Latvia, Lithuania

Outcome results

None listed

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