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

Novartis347 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

347

Conditions

Essential Hypertension

Interventions

Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZDRUG

Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Investigative Site

Pirna, Germany

Outcomes

Primary Outcomes

Change in mean sitting diastolic blood pressure after 4 weeks of treatment

Time frame: 4 weeks

Secondary Outcomes

Change in mean sitting systolic blood pressure reduction after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT

Time frame: 4 weeks

Change in mean sitting diastolic blood pressure after 4 weeks of treatment with Aliskiren/Amlodipine/HCT

Time frame: 4 weeks

Change in heart rate, pulse pressure, responder rates, normalization rates after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT

Time frame: 4 weeks

Data from ClinicalTrials.gov

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