Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Amlodipine+valsartan; Drug: Olmesartan medoxomil; Drug: Amlodipine; Drug: Hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00523744

CVAA489ADE06

Details and patient eligibility

About

This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).

Full description

Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg

Enrollment: 257 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Core study:

• Male or female patients (>=18 years)
• Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods
• Patients with essential hypertension (diastolic blood pressure >=100 mmHg and <110 mmHg)

Inclusion Criteria for Extension:

• Patients had to have a msSBP >= 140 mmHg and/or msDBP >= 90 mmHg at week 8 ie, end of core study.

Exclusion Criteria for Core study:

• Severe hypertension (diastolic blood pressure >=110 mmHg or systolic blood pressure >= 180 mmHg)
• Pregnant or nursing women
• Treated hypertensive patients with controlled hypertension under current therapy
• A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Exclusion Criteria for Extension:

• prematurely discontinued the core study
• failed to comply with the core study protocol

Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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257 participants in 1 patient group

Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ

Experimental group

Description:

During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.

Treatment:

Drug: Hydrochlorothiazide

Drug: Olmesartan medoxomil

Drug: Amlodipine

Drug: Amlodipine+valsartan