NCT00933920
Completed
Phase 1
A Randomized, Single-blind, Parallel Group, Multiple Oral Dose Study to Evaluate the Effect of a Light Meal on the Pharmacokinetics and Pharmacodynamics of Aliskiren Using Market 300 mg Tablet Formulation in Subjects With Mild to Moderate Hypertension
Overview
- Phase
- Phase 1
- Intervention
- Aliskiren
- Conditions
- Hypertension
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 124
- Locations
- 2
- Primary Endpoint
- Compare PK (AUC & Cmax) and PD, i.e. PRA (Plasma Renin Activity, AUE) of aliskiren when given with and without light meal.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
Fed Group
Intervention: Aliskiren
Fasted group
Intervention: Aliskiren
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
Study Sites (2)
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