Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine (AWESOME)

Novartis

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

Study type: Interventional

Funder types: Industry

Identifiers

NCT01113047

CSPA100ADE01

Details and patient eligibility

About

This study will assess the efficacy and safety of the single pill combination of Aliskiren and Amlodipine in patients with moderate hypertension not adequately responding to a single pill combination of Olmesartan and Amlodipine.

Further this study will also assess the efficacy and safety of a single pill combination of Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension not adequately responding to a single pill combination of Aliskiren and Amlodipine.

Enrollment: 347 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Essential hypertension stage II
• Male and female patients
• Age >= 18 years old

Exclusion criteria

• Severe hypertension (systolic BP >= 180 mmHg, diastolic BP >= 110 mmHg
• Poorly controlled diabetes mellitus or type 1 DM
• History of myocardial infarction, stroke
• Presence of heart failure
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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347 participants in 1 patient group

Non responder Olmesartan/Amlodipine

Experimental group

Description:

Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

Treatment:

Drug: Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ