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

• Conditions: ncontrolled essential hypertension; MedDRA version: 17.0Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001658-24-BG
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-27
• Last Update Posted: 21 September 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 (left ventricular hypertrophy is authorized at selection and during the study).
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

- Creatinine clearance value classifying them as moderate or severe renal failure
- 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.

Study & Design

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