A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg

November 16, 2016 updated by: Novartis

A 4 Month Extension to a 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long-term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension

The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

250

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

  • Belgium
      • Deurne, Belgium
        • Investigative Site
  • Canada
      • Ste-Fov, Canada
        • Investigative Site
  • Germany
      • Krassel, Germany
        • Investigative Site
  • Italy
      • Broni, Italy
        • Investigative Site
  • Netherlands
      • Rotterdam, Netherlands
        • Investigative Site
  • Peru
      • Lima, Peru
        • Investigative Site
  • Russian Federation
      • Moscow, Russian Federation
        • Investigative Site
  • Switzerland
      • Basel, Switzerland
        • Investigative Site
  • United Kingdom
      • London, United Kingdom
        • Investigative Site
  • United States
    • New Jersey
      • East Hanover, New Jersey, United States
        • Investigative Site

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:

  1. their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study.
  2. absence of ongoing severe adverse events at Visit 10.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study

Secondary Outcome Measures

Outcome Measure
Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months
Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months
Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months
Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline
Blood pressure less than 140/90 mmHg

Collaborators and Investigators

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

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2005

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

August 24, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPP100A2302E1

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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