8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension

November 7, 2011 updated by: Novartis

An 8-week, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Valsartan/HCTZ/Amlodipine Compared to Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in Patients With Moderate to Severe Hypertension.

The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2279

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
      • E. Hanover, New Jersey, United States, 07936
        • Novartis Pharmaceuticals Corporation

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and < 120 mmHg, MSSBP ≥ 145 mmHg and < 200 mmHg).

Exclusion Criteria:

  • Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit 1.
  • Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and < 110 mmHg, and/or MSSBP ≥ 140 mmHg and < 180 mmHg at Visit 1.
  • Patients on four or more antihypertensive drugs at Visit 1.
  • Arm circumference > 42 cm for patients participating in ABPM.

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 diastolic blood pressure after 8 weeks
Change from baseline systolic blood pressure after 8 weeks

Secondary Outcome Measures

Outcome Measure
Blood pressure less than 140/90 mmHg after 8 weeks
Systolic blood pressure less than 140 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks
Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease after 8 weeks or systolic blood pressure less than 140 mmHg or at least a 15 mmHg decrease after 8 weeks
Ambulatory blood pressure and standing systolic and diastolic blood pressure measurements
Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 8 weeks

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

May 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 16, 2006

First Submitted That Met QC Criteria

May 16, 2006

First Posted (Estimate)

May 18, 2006

Study Record Updates

Last Update Posted (Estimate)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVEA489A2302

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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