Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-Moderate Hypertension.
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: valsartan + HCTZ (Drug); Valsartan (Drug); HCTZ (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Pharmaceuticals Overall contact:
Novartis Pharmaceuticals, Phone: 862-778-8300
Summary
The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy
with valsartan/HCTZ versus the initial treatment therapy with monotherapies (valsartan or
hydrochlorothiazide 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 Monotherapy in Very Elderly Patients With Essential Hypertension
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in mean sitting sitting systolic blood pressure (MSSBP)
Secondary outcome: Change in office cuff mean sitting diastolic blood pressure (MSDBP)Change in office cuff mean sitting systolic blood pressure (MSSBP) Percent of patients achieving BP control (defined as BP < 140/90 mmHg) Percent of patients achieving BP goal (SBP<140 mmHg) Time to achieving the first treatment success (defined as the time of the first achievement of the target blood pressure goal (<140 and <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 inclusion/exclusion criteria may apply
Locations and Contacts
Novartis Pharmaceuticals, Phone: 862-778-8300
Investigative site, Birmingham, Alabama, United States; Recruiting
Email: sgreen@uab.edu
Investigative site, Phoenix, Arizona, United States; Recruiting
Investigative Sites, Pismo Beach, California, United States; Recruiting
Investigative site, Fresno, California, United States; Recruiting
Investigative Site, Escondido, California, United States; Recruiting
Investigative site, Huntington Park, California, United States; Recruiting
Investigative site, Ormond Beach, Florida, United States; Recruiting
Investigative site, Miami, Florida, United States; Recruiting
Investigative site, Conyers, Georgia, United States; Recruiting
Investigative Site, Lexington, Kentucky, United States; Recruiting
Investigative site, Portland, Maine, United States; Recruiting
Investigative site, Las Vegas, Nevada, United States; Recruiting
Investigative site, Buffalo, New York, United States; Recruiting
Investigative site, Shelby, North Carolina, United States; Recruiting
Investigative site, Carlisle, Ohio, United States; Recruiting
Investigative site, Oklahoma City, Oklahoma, United States; Recruiting
Investigative site, Erie, Pennsylvania, United States; Recruiting
Investigative Site, Taylors, South Carolina, United States; Recruiting
Investigative Site, Greer, South Carolina, United States; Recruiting
Investigative site, St George, Utah, United States; Recruiting
Additional Information
Click here for more information on the clinical study
Starting date: April 2008
Ending date: April 2009
Last updated: December 16, 2008
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