Safety and efficacy of fixed dose combination of Indapamide SR 1.5 mg / Amlodipine versus Valsartan / Amlodipine over 12-week of treatment in patients with uncontrolled essential hypertension after 1 month of treatment by Amlodipine 5 mg.

Safety and efficacy of fixed dose combination of Indapamide SR 1.5 mg / Amlodipine versus Valsartan / Amlodipine over 12-week of treatment with conditional titration based on the blood pressure control, in patients with uncontrolled essential hypertension after 1 month of Amlodipine 5 mg run-in treatment. An international, randomized, double-blind, multicenter controlled study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001690-84-GB

Enrollment

448

Registered

2013-04-09

Start date

2013-08-22

Completion date

Unknown

Last updated

2019-06-30

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: 14.1 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: S05520 Product Code: S05520 Pharmaceutical Form: Modified-release film-coated tablet INN or Proposed INN: INDAPAMIDE CAS N

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, - Normal or without any clinically significant anomaly 12-lead ECG (LVH authorized). 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 363 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85

Exclusion criteria

Exclusion criteria: -Patients treated for hypertension with more than one antihypertensive drug at inclusion. -History of hypertension known to be resistant to the free or fixed bi-therapy combination with sartans, diuretics and calcium channel inhibitors or contra-indications to treatment with them. -Patient with history of intolerance with one or several of the study drugs, either valsartan, amlodipine or indapamide. -Secondary hypertension (known renal parenchymal hypertension, renovascular hypertension, pheochromocytoma, Cushing’s syndrome, coarctation of the aorta, drug-induced hypertension, liquorice-induced hypertension and especially primary hyperaldosteronism). -Known complicated hypertension: known stage III or IV hypertensive retinopathy, macroalbuminuria. -Lymphedema or leg edema (bilateral). -Orthostatic hypotension at inclusion. -Positive pregnancy test or results not available.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate better efficacy of fixed-dose combination strategy Indapamide SR 1.5 mg/Amlodipine versus Valsartan/Amlodipine fixed-dose in lowering office systolic blood pressure at W12.; Secondary Objective: -To assess the response to the treatment and normalisation of blood pressure at each visit according to the uptitration strategy. -To assess the efficacy of both combination strategies on the Ambulatory Blood Pressure Monitoring (ABPM) parameters after 12-week (W12) of treatment-To assess the efficacy of both combination strategies on the home blood pressure monitoring (HBPM) parameters at each week and each visit until the study end (W12). -To assess the safety of each dose of the Indapamide SR 1.5 mg/ Amlodipine and Valsartan/Amlodipine combinations after 12 weeks of treatment. ;Primary end point(s): -Supine systolic blood pressure;Timepoint(s) of evaluation of this end point: From baseline to the last post-baseline value achieved in W0-W12 period.	—

Measure

Time frame

Main Objective: To demonstrate better efficacy of fixed-dose combination strategy Indapamide SR 1.5 mg/Amlodipine versus Valsartan/Amlodipine fixed-dose in lowering office systolic blood pressure at W12.; Secondary Objective: -To assess the response to the treatment and normalisation of blood pressure at each visit according to the uptitration strategy. -To assess the efficacy of both combination strategies on the Ambulatory Blood Pressure Monitoring (ABPM) parameters after 12-week (W12) of treatment-To assess the efficacy of both combination strategies on the home blood pressure monitoring (HBPM) parameters at each week and each visit until the study end (W12). -To assess the safety of each dose of the Indapamide SR 1.5 mg/ Amlodipine and Valsartan/Amlodipine combinations after 12 weeks of treatment. ;Primary end point(s): -Supine systolic blood pressure;Timepoint(s) of evaluation of this end point: From baseline to the last post-baseline value achieved in W0-W12 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, Hungary, Latvia, Lithuania, Mexico, Poland, Romania, Russian Federation, South Africa, Thailand, Turkey, Ukraine, United Kingdom, Vietnam

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33155724366

Outcome results

None listed

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