The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy (EXTRA)

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: valsartan and amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00666536

CVAA489AUS02

Details and patient eligibility

About

The purpose of this trial is to compare blood pressure lowering efficacy of moderate Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan

Enrollment: 728 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female outpatients
• 18 Years of age or older
• Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 150 mmHg and lower than 200 mmHg while on Angiotensin-Receptor Blocker monotherapy for a minimum period of 28 days prior to randomization

Exclusion criteria

• Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 200 mmHg and/or Mean Sitting Diastolic Blood Pressure greater than or equal to 120 mmHg
• Transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all types of revascularization procedures in the last 6 months
• Treatment with valsartan or any combination antihypertensive treatment with 28 days prior to screening (Visit 1)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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728 participants in 2 patient groups

Aggressive treatment regimen (5/320 mg to 10/320 mg)

Active Comparator group

Description:

Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)

Treatment:

Drug: valsartan and amlodipine

Drug: valsartan and amlodipine

Moderate treatment regimen (5/160 mg)

Active Comparator group

Description:

Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)

Treatment:

Drug: valsartan and amlodipine

Drug: valsartan and amlodipine