NCT00933920

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for phase_1 hypertension

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

December 21, 2020

Status Verified

February 1, 2010

Enrollment Period

6 months

First QC Date

July 3, 2009

Last Update Submit

December 17, 2020

Conditions

Hypertension

Keywords

Aliskiren,hypertension,renin-angiotensin-aldosterone system,pharmacokinetics,pharmacodynamics

Outcome Measures

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.

    28 Days

Secondary Outcomes (3)

  • 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 Arms (2)

Fed Group

ACTIVE COMPARATOR
Drug: Aliskiren

Fasted group

ACTIVE COMPARATOR
Drug: Aliskiren

Interventions

AliskirenDRUG
Fed Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Novartis Investigator Site

Coimbatore, India

Location

Novartis Investigative Site

Hyderabaad, India

Location

Novartis Investigator Site

Hyderabaad, India

Location

Novartis Investigator Site

Mangalore, India

Location

Novartis Investigative Site

New Delhi, India

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 3, 2009

First Posted

July 7, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Last Updated

December 21, 2020

Record last verified: 2010-02

Locations

IN(5)