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.

Phase 1

• Conditions: ncontrolled essential hypertension; MedDRA version: 14.1 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-09
• Study Completion: 2015-02-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 473

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