Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension (AMAZING)

Novartis

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: Candesartan+HCTZ - Phase 1

Drug: Aliskiren+HCTZ+amlodipine - Phase 3

Drug: Aliskiren+HCTZ - Phase 2

Study type

Interventional

Funder types

Industry

Identifiers

NCT00867490

CSPH100ADE01

Details and patient eligibility

About

This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide (HCTZ) in patients who do not achieve controlled blood pressure levels after treatment with another specified antihypertensive medication. There was an optional study extension for the first eligible 60 patients who wanted to participate that contains the triple therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg.

Full description

Title of study extension: An open-label, multicenter extension to evaluate the efficacy and safety of a 4 week therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of candesartan 32 mg plus hydrochlorothiazide 25 mg followed by aliskiren 300mg plus hydrochlorothiazide 25 mg

Enrollment

186 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Core Study:

Patients with mean sitting diastolic blood pressure ≥ 100 mmHg and < 110 mmHg

Inclusion criteria for the Extension:

msSBP ≥ 140 mm Hg and/or msDBP ≥ 90 mm Hg at Visit 5 of the core study

Exclusion Criteria for Core Study:

Patients with mean diastolic blood pressure ≥ 110 mmHg or mean systolic blood pressure ≥ 180 mmHg
Patients with prior stroke, hypertensive encephalopathy or heart attack
Patients with type 1 diabetes mellitus
Patients with type 2 diabetes mellitus with poor glucose control

Exclusion criteria for the Extension:

Premature discontinuation in the core study or failure to comply with the core study protocol
History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, known or suspected contraindications to diuretics as described in the SmPC (particularly amlodipine 5 mg), e.g. severe hypotension, shock - including cardiogenic shock, obstructions impairing the flow out of the left ventricle (e.g. significant aortic stenosis)
Any patient that the investigator decides should not participate in the extension study for medical reasons

Other protocol-defined inclusion/exclusion criteria applied to the study.