Efficacy and safety of fixed-dose combination Perindopril / Indapamide / Amlodipine versus Perindopril / Indapamide single pill in patients with uncontrolled essential hypertension after 1 month of treatment by Perindopril / Indapamide

Efficacy and safety of fixed-dose combination Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg versus Perindopril 5 mg / Indapamide 1.25 mg single pill in patients with uncontrolled essential hypertension after 1 month of treatment by Perindopril 5 mg / Indapamide 1.25 mg single pill with conditional titration based on blood pressure control up to Perindopril 10 mg/ Indapamide 2.5 mg / Amlodipine 10 mg. An international, multicentre, randomised, double blind, 12-weeks superiority study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001658-24-SK

Enrollment

448

Registered

2012-09-14

Start date

2013-03-12

Completion date

Unknown

Last updated

2015-09-14

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

Conditions

Uncontrolled essential hypertension MedDRA version: 15.0 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: S06593 Product Code: S06593 Pharmaceutical Form: Capsule CAS Number: 82834-16-0 Current Sponsor code: S9490-6 Other descriptive name: PERINDOPRIL ARGININE Concentration unit: mg/g millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Men or women of any ethnic origin, - Age = 18 years old or legal national majority, - Confirmed essential uncontrolled hypertension, - Creatinine clearance greater than or equal to 60 ml/min, - Results of laboratory examinations collected at selection without any clinically significant anomaly, - Normal or without any clinically significant anomaly 12-lead ECG. 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 314 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 134

Exclusion criteria

Exclusion criteria: - History of hypertension known to be resistant to the free or fixed three-therapy combination with ACE-inhibitors, diuretics and calcium channel inhibitors, - Treatment with more than 2 antihypertensive drugs at the selection visit, - Allergy, hypersensitivity, history of intolerance to indapamide or to any other sulphonamides, to perindopril or any other ACE inhibitor, to amlodipine or any other dihydropyridine, or to any of the excipients, - Congenital galactose intolerance, glucose and galactose malabsorption syndrome, deficit on lactase.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the superiority effect of fixed-dose combination Perindopril / Indapamide / Amlodipine in single-pill versus bi-therapy in single pill in lowering office systolic blood pressure at the end of one month of treatment.;Secondary Objective: - To assess the effect of fixed-dose combination Perindopril/ Indapamide/ Amlodipine in single-pill on Blood Pressure parameters according to the uptitration strategy - To assess the safety and tolerability of each dose of Perindopril/ Indapamide/ Amlodipine.;Primary end point(s): Supine systolic blood pressure;Timepoint(s) of evaluation of this end point: From baseline to post-baseline value achieved in M0-M1 period.	—

Measure

Time frame

Main Objective: To demonstrate the superiority effect of fixed-dose combination Perindopril / Indapamide / Amlodipine in single-pill versus bi-therapy in single pill in lowering office systolic blood pressure at the end of one month of treatment.;Secondary Objective: - To assess the effect of fixed-dose combination Perindopril/ Indapamide/ Amlodipine in single-pill on Blood Pressure parameters according to the uptitration strategy - To assess the safety and tolerability of each dose of Perindopril/ Indapamide/ Amlodipine.;Primary end point(s): Supine systolic blood pressure;Timepoint(s) of evaluation of this end point: From baseline to post-baseline value achieved in M0-M1 period.

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Secondary

Measure	Time frame
Secondary end point(s): - Other blood pressure parameters, - Physical examination, - Adverse events, - Laboratory examinations.;Timepoint(s) of evaluation of this end point: Over the study.	—

Countries

Argentina, Brazil, Bulgaria, Czech Republic, Hungary, Poland, Romania, Russian Federation, Singapore, Slovakia, South Africa, Ukraine, Vietnam

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com0155724366

Outcome results

None listed

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