Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg (EXPLOR)

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Atenolol 100 mg tablets; Drug: Atenolol 50 mg tablets; Drug: Amlodipine 10 mg capsules; Drug: Amlodipine 5 mg capsules; Drug: Valsartan/amlodipine 80/5 mg tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00687973

CVAA489AFR02

Details and patient eligibility

About

Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen.

Enrollment: 393 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients 18 years of age or older
• Hypertension defined by MSDBP > 90 and or MSSBP > 140 mmHg, MSDBP > 80 mmHg, or/and MSSBP > 130 mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects
• Written informed consent to participate in the study prior to any study procedures

Exclusion criteria

• Severe hypertension (grade 3 WHO classification MSDBP > 110 mmHg and/or MSSBP > 180 mmHg)
• Evidence of a secondary form of hypertension
• Type 1 diabetes mellitus
• History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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393 participants in 2 patient groups

Valsartan/amlodipine 160/10 mg

Experimental group

Description:

Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.

Treatment:

Drug: Valsartan/amlodipine 80/5 mg tablets

Atenolol/amlodipine 100/10 mg

Active Comparator group

Description:

Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.

Treatment:

Drug: Atenolol 100 mg tablets

Drug: Amlodipine 10 mg capsules

Drug: Amlodipine 5 mg capsules

Drug: Atenolol 50 mg tablets