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

Condition(s) targeted: Hypertension

Intervention: Atenolol (Drug); Hydrochlorothiazide (HCTZ)) (Drug); Valsartan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharma Ag, Principal Investigator, Affiliation: Novartis Pharmaceuticals

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.

Official title: A Randomized, Open-label, Multicenter, Cross-over Trial to Evaluate the Efficacy of a 20 Week Treatment of Valsartan 320 mg Versus Atenolol 100 mg in Combination With Hydrochlorothiazide on Microcirculation in Hypertensive Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites

Secondary outcome:

Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected Sites

Difference in Mean Post-treatment Microcirculation at a Sodium Nitroprusside Injected Site Compared to NaCl Injected Sites

Mean Post-treatment Microcirculation at NaCl Injected Sites

Arterial Pressure Waveform Augmentation Index at the End of Treatment

Arterial Pressure Waveform Pulse Wave Velocity at the End of Treatment

Minimum age: 40 Years. Maximum age: 65 Years. Gender(s): Both.

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).

Investigative Centers, Germany

Novartis Pharma Ag, Basel, Switzerland

Starting date: December 2005
Last updated: May 5, 2011