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.

• Conditions: ncontrolled essential hypertension; MedDRA version: 16.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001690-84-HU
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-12
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 448

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>­-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).<br>-To assess the safety of each dose of the Indapamide SR 1.5 mg/ Amlodipine and Valsartan/Amlodipine combinations after 12 weeks of treatment.<br>;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.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Other blood pressure parameters,<br>- Physical examination,<br>- Adverse events,<br>- Laboratory examinations.;Timepoint(s) of evaluation of this end point: Over the study.