Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension (EXALT)

Novartis

Status and phase: Completed; Phase 4

Conditions: Stage 2 Systolic Hypertension

Treatments: Drug: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ; Drug: valsartan, amlodipine, HCTZ

Study type: Interventional

Funder types: Industry

Identifiers

NCT00931710

CVEA489AUS01

Details and patient eligibility

About

This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).

Enrollment: 488 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female outpatient of 18 years of age or greater
• Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure (MSSBP) greater than or equal to 160 and < 200 mmHg at randomization
• Patients who were able to participate in the study, and who gave written informed consent before any study assessment was performed.

Exclusion criteria

• Office systolic blood pressure >200 and/or mean sitting diastolic blood pressure (MSDBP) greater than or equal to 110 mmHg at Visit 1.
• Use of four (4) or more antihypertensive medications within 30 days of Visit 1.
• Refractory hypertension, defined as blood pressure >140/90 mmHg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with a fixed-dose combination of two active medications represents two drugs).
• Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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488 participants in 2 patient groups

Valsartan/amlodipine/HCTZ

Experimental group

Description:

Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.

Treatment:

Drug: valsartan, amlodipine, HCTZ

Losartan/HCTZ

Active Comparator group

Description:

Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.

Treatment:

Drug: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ