Status:
COMPLETED
Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
70+ years
Phase:
PHASE4
Brief 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 (valsarta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT00698646
Start Date
April 1 2008
End Date
June 1 2009
Last Update
April 19 2011
Active Locations (20)
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1
Investigative site
Birmingham, Alabama, United States
2
Investigative site
Phoenix, Arizona, United States
3
Investigative Site
Escondido, California, United States
4
Investigative site
Fresno, California, United States