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

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Valsartan + HCTZ (Drug); Valsartan (Drug); HCTZ (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)

Secondary outcome:

Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)

Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)

Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg

Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)

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])

Eligibility

Minimum age: 70 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Investigative site, Birmingham, Alabama, United States

Investigative site, Phoenix, Arizona, United States

Investigative Site, Escondido, California, United States

Investigative site, Fresno, California, United States

Investigative site, Huntington Park, California, United States

Investigative Sites, Pismo Beach, California, United States

Investigative site, Miami, Florida, United States

Investigative site, Ormond Beach, Florida, United States

Investigative site, Conyers, Georgia, United States

Investigative Site, Lexington, Kentucky, United States

Investigative site, Portland, Maine, United States

Investigative site, Las Vegas, Nevada, United States

Investigative site, Buffalo, New York, United States

Investigative site, Shelby, North Carolina, United States

Investigative site, Carlisle, Ohio, United States

Investigative site, Oklahoma City, Oklahoma, United States

Investigative site, Erie, Pennsylvania, United States

Investigative Site, Greer, South Carolina, United States

Investigative Site, Taylors, South Carolina, United States

Investigative site, St George, Utah, United States

Additional Information

Click here for more information on the clinical study

Starting date: April 2008
Last updated: April 15, 2011

Page last updated: August 20, 2015

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