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Completed

NCT Number: NCT00933920

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigator Site, Coimbatore, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. 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

  1. Compare the effect of Plasma Renin Concentration (PRC) and angiotensin II of aliskiren when given with and without light meal

    Time frame: 28 Days

  2. Assess safety and tolerability of aliskiren when given with and without light meal

    Time frame: 28 days

  3. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
First posted
Jul 7, 2009
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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