Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients

Last updated: May 5, 2011
Sponsor: Novartis
Overall Status: Completed

Phase

3

Condition

Vascular Diseases

Circulation Disorders

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT00396656
CVAH631BDE06
  • Ages 40-65
  • All Genders

Study Summary

This study evaluated the effect of valsartan on small vessel blood flow in patients with mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Caucasian; male or female outpatients and age between 40-65 years of age, inclusive.

  • At Visit 2 all patients must have a mean sitting diastolic blood pressure (msSBP) of ≥ 90 mmHg and < 110 mmHg.

Exclusion

Exclusion Criteria:

  • If a single reading for arterial hypertension in msSBP > 180 mmHg or msDBP > 110 mmHgat any visit after randomization.

  • Inability to discontinue all prior antihypertensive medications safely for a period of 2 weeks prior to randomization.

  • Known history of hypotensive symptoms or orthostatic hypotension.

  • Concomitant use of statins or statin intake during the four weeks prior to Visit 1.

  • Known Keith-Wagener grade III or IV hypertensive retinopathy.

  • A history of heart failure (NYHA II-IV).

Study Design

Total Participants: 30
Study Start date:
December 01, 2005
Estimated Completion Date:
December 31, 2007

Connect with a study center

  • Investigative Centers,
    Germany

    Site Not Available

  • Novartis Pharma Ag

    Basel,
    Switzerland

    Site Not Available

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