A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients

Novartis881 enrolled

Overview

Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to aliskiren 300 mg.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

881

Conditions

Hypertension

Interventions

Aliskiren/HCTZDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female outpatients 18 years old or older. * Patients with a diagnosis of hypertension. * Patients who are eligible and consent to participate in the study Exclusion Criteria: * Severe hypertension * Previous or current diagnosis of heart failure. * History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). * Other protocol-defined inclusion/exclusion criteria may apply

Locations (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Unnamed facility

Investigative Centers, Germany

Outcomes

Primary Outcomes

Mean Sitting Diastolic Blood Pressure lowering effect at baseline, and week 8.

Secondary Outcomes

Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8

Safety and tolerability

Proportion of patients achieving a blood pressure control target at week 8

Data from ClinicalTrials.gov

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