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

Condition(s) targeted: Hypertension; Hypertrophy, Left Ventricular

Intervention: Amlodipine + Valsartan (Drug); Losartan + Hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis

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

Official title: An Open-Label, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Amlodipine in Combination With Valsartan Compared to Losartan in Combination With Hydrochlorothiazide Given for 52 Weeks on the Regression of Left Ventricular Hypertrophy in Patients With Mild to Moderate Hypertension

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To compare the combination of valsartan 160mg and amlodipine 5mg with the combination of losartan 100mg and HCTZ 12.5mg with regard to regression of left ventricular hypertrophy (echo) after 12 months of treatment

Secondary outcome:

To compare the combination of val 160mg and aml 5mg with the combination of losartan 100mg and HCTZ 12.5mg with regard to a change in parameters such as left ventricular wall thickness, left ventricular ejection fraction, left ventricular end

To compare the combination of val 160mg and aml 5mg with the combination of losartan 100mg and HCTZ 12.5mg with regard to the impact of both combinations on the change in NT-proBNP and High-Sensitivity C-Reactive Protein.

To evaluate the overall safety and tolerability of the combination of val 160mg and aml5mg compared with the combination of losartan 100mg and HCTZ 12.5mg in patients with essential hypertension and left ventricular hypertrophy

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

25 centers in Germany, Ludwigshafen, Germany

Starting date: March 2007
Last updated: September 21, 2007