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

Completed · Phase 4

Conditions studied: Hypertension

In brief

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

Key facts

Study ID

NCT00698646

Run by

Novartis Pharmaceuticals

People needed

384

Starts

2008-04-01

Expected to finish

2009-06-01

Last updated by the study team

2011-04-19

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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