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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00396656

CVAH631BDE06

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Valsartan followed by atenolol + hydrochlorothiazide (HCTZ)

Experimental group

Description:

After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning. After a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.

Treatment:

Drug: Atenolol

Drug: Hydrochlorothiazide (HCTZ))

Drug: Valsartan

Atenolol + hydrochlorothiazide (HCTZ) followed by valsartan

Experimental group

Description:

After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning. After a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning.

Treatment:

Drug: Atenolol

Drug: Hydrochlorothiazide (HCTZ))

Drug: Valsartan