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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Atenolol; Hydrochlorothiazide; Valsartan

Criteria

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 Criteria:

• If a single reading for arterial hypertension in msSBP > 180 mmHg or msDBP > 110 mmHg at 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).