Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension; Hypertrophy, Left Ventricular

Treatments: Drug: Hydrochlorothiazide; Drug: Valsartan; Drug: Losartan; Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00446563

CVAA489ADE02

Details and patient eligibility

About

This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Caucasian; male or female outpatients and age between 18-80 years of age, inclusive.
• Patients with a history of essential hypertension and who are actually treated either with an antihypertensive monotherapy and with a diastolic blood pressure >=90 and <= 105mmHg or with a combination therapy (limited to two active compounds) and with a diastolic blood pressure of >=90 and <= 100mmHg.
• Patients with Left Ventricular Hypertrophy

Exclusion criteria

• Severe hypertension
• Symptomatic heart failure
• History of stroke, heart attack, coronary bypass surgery etc.
• Insulin-dependent diabetes mellitus or poorly controlled diabetes mellitus.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Amlodipine + Valsartan

Experimental group

Description:

Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.

Treatment:

Drug: Amlodipine

Drug: Valsartan

Losartan + Hydrochlorothiazide

Active Comparator group

Description:

Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.

Treatment:

Drug: Hydrochlorothiazide

Drug: Losartan