Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate Hypertension

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Aliskiren

• Registration Number: NCT00933920
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-03
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Primary Completion: 2009-12
• Status Verified: 2010-02
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Male or female outpatients, 18 to 65 years of age with mild to moderate hypertension
• Patients who are eligible and able to participate in the study

Exclusion criteria:

• Severe hypertension
• Secondary form of hypertension.
• Type 1 or type 2 diabetes mellitus
• Serum potassium out side laboratory reference range
• Any history of hypertensive encephalopathy or cerebrovascular accident

Other protocol-defined inclusion/exclusion criteria may apply

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fed Group	Aliskiren	-
Fasted group	Aliskiren	-

Primary Outcome Measures

Name	Time	Method
Compare PK (AUC & Cmax) and PD, i.e. PRA (Plasma Renin Activity, AUE) of aliskiren when given with and without light meal.	28 Days

Secondary Outcome Measures

Name	Time	Method
Compare the effect of Plasma Renin Concentration (PRC) and angiotensin II of aliskiren when given with and without light meal	28 Days
Assess safety and tolerability of aliskiren when given with and without light meal	28 days
Evaluate the effect on mean sitting systolic and diastolic blood pressure of aliskiren when given with or without a light meal	28 days

Trial Locations

Locations (2)

Novartis Investigative Site; 🇮🇳 New Delhi, India

Novartis Investigator Site; 🇮🇳 Mangalore, India