The purpose of this study is to determine the effect of a light meal on the pharmacokinetics and pharmacodynamics of aliskiren in patients with mild to moderate hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
124
Novartis Investigator Site
Coimbatore, India
Novartis Investigative Site
Hyderabaad, India
Novartis Investigator Site
Hyderabaad, India
Novartis Investigator Site
Mangalore, India
Novartis Investigative Site
Compare PK (AUC & Cmax) and PD, i.e. PRA (Plasma Renin Activity, AUE) of aliskiren when given with and without light meal.
Time frame: 28 Days
Compare the effect of Plasma Renin Concentration (PRC) and angiotensin II of aliskiren when given with and without light meal
Time frame: 28 Days
Assess safety and tolerability of aliskiren when given with and without light meal
Time frame: 28 days
Evaluate the effect on mean sitting systolic and diastolic blood pressure of aliskiren when given with or without a light meal
Time frame: 28 days
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New Delhi, India