A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren 150mg, 300mg, and 600mg to Placebo in Patients With High Blood Pressure.

November 7, 2011 updated by: Novartis

An Eight-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing Aliskiren 150 mg, 300 mg, and 600 mg to Placebo in Patients With Essential Hypertension

Evaluate the blood pressure lowering effect of aliskiren 150mg, 300mg and 600mg compared to placebo in patients with essential hypertension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

671

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Patients with essential hypertension
  • Patients who are eligible and able to participate in the study

Exclusion Criteria

  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcome Measures

Outcome Measure
Change from baseline in systolic blood pressure after 8 weeks
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 weeks and 8 weeks
Blood pressure <140/90 mmHg after 4 weeks and 8 weeks
Evaluate potential return of hypertension at 4 days and 2 weeks after 8 weeks
Evaluate high and low level drug effect using 24 hour blood pressure monitoring

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPP100A2308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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