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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Valsartan

Primary Measures

• Microcirculation following intradermal application of acetylcholine in patients with mild to moderate essential hypertension at baseline, 20 weeks.

Secondary Measures

• Microcirculation following intradermal application of acetylcholine in the presence of L-NMMA in patients with mild to moderate essential hypertension at baseline, 20 weeks.
• Vascular responses to individual dosages of provocation test substances such as acetylcholine with or without L-NMMA, L-NMMA alone and Sodium nitroprusside.
• Microcirculation following intradermal application of a sodium chloride solution in patients with mild to moderate essential hypertension at baseline, 20 weeks
• Arterial stiffness markers and pulse wave reflection
• Safety and tolerability.

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 mm Hg or MSDBP of 110 mm
• Hg 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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharma Ag Principal Investigator Novartis  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00396656

Study ID Number: CVAH631BDE06

ClinicalTrials.gov Identifier: NCT00396656

Health Authority: Germany: Federal Institute for Drugs and Medical Devices