Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.

April 15, 2011 updated by: Novartis Pharmaceuticals

A 16 Week Multi-center, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Valsartan/Hydrochlorothiazide (HCTZ) Combination Therapy Compared to Patients Initiated With Valsartan Monotherapy or Hydrochlorothiazide (HCTZ) Monotherapy in Very Elderly Patients With Essential Hypertension

The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

384

Phase

  • Phase 4

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
    • Alabama
      • Birmingham, Alabama, United States
        • Investigative Site
    • Arizona
      • Phoenix, Arizona, United States
        • Investigative Site
    • California
      • Escondido, California, United States
        • Investigative Site
      • Fresno, California, United States
        • Investigative Site
      • Huntington Park, California, United States
        • Investigative Site
      • Pismo Beach, California, United States
        • Investigative Sites
    • Florida
      • Miami, Florida, United States
        • Investigative Site
      • Ormond Beach, Florida, United States
        • Investigative Site
    • Georgia
      • Conyers, Georgia, United States
        • Investigative Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Investigative Site
    • Maine
      • Portland, Maine, United States
        • Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Investigative Site
    • New York
      • Buffalo, New York, United States
        • Investigative Site
    • North Carolina
      • Shelby, North Carolina, United States
        • Investigative Site
    • Ohio
      • Carlisle, Ohio, United States
        • Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Investigative Site
    • Pennsylvania
      • Erie, Pennsylvania, United States
        • Investigative Site
    • South Carolina
      • Greer, South Carolina, United States
        • Investigative Site
      • Taylors, South Carolina, United States
        • Investigative Site
    • Utah
      • St George, Utah, 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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 70 years or older.
  • Patients with hypertension prior to being randomized into study.
  • Patients must have an office cuff MSSBP ≥ 140 and ≤ 200 mmHg systolic.
  • Have the ability to communicate and comply with all study requirements.
  • Provide written informed consent to participate in the study prior to any screening or study procedures.

Exclusion Criteria:

  • Use of other investigational drugs within 30 days of enrollment.
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
  • Office blood pressure measured by office machine cuff with a mean of (3) MSDBP ≥ 120 mmHg at anytime during the screening / washout period.
  • Patients taking 3 or more antihypertensive drugs and MSSBP ≥ 160 mmHg at the time of Visit 1.
  • 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Valsartan
(patients initiated on valsartan)
Drug: Valsartan
At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
Active Comparator: HCTZ
(patients initiated on HCTZ)
Drug: HCTZ
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
Experimental: Valsartan + HCTZ
(patients initiated on Valsartan+HCTZ)
Drug: Valsartan + HCTZ
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Time Frame: Baseline and Week 4
Baseline and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
Time Frame: Baseline and Weeks 4, 8, 12 and 16
Baseline and Weeks 4, 8, 12 and 16
Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Time Frame: Baseline and Weeks 8, 12, and 16
Baseline and Weeks 8, 12, and 16
Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg
Time Frame: Weeks 4, 8, 12 and 16
Cumulative refers to achieving of blood pressure control before or at the corresponding visit.
Weeks 4, 8, 12 and 16
Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)
Time Frame: Weeks 4, 8, 12 and 16
Cumulative refers to achieving blood pressure goal before or at the corresponding visit.
Weeks 4, 8, 12 and 16
Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])
Time Frame: During 16 weeks
During 16 weeks

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

Helpful Links

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

April 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Estimate)

April 19, 2011

Last Update Submitted That Met QC Criteria

April 15, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVAH631BUS08

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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