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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00446563

Purpose

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

Condition	Intervention	Phase
Hypertension; Hypertrophy, Left Ventricular	Drug: Amlodipine + Valsartan Drug: Losartan + Hydrochlorothiazide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Losartan Losartan potassium Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	150
Study Start Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446563

Locations

Germany
25 centers in Germany
Ludwigshafen, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Study ID Numbers:	CVAA489ADE02
Study First Received:	March 12, 2007
Last Updated:	September 21, 2007
ClinicalTrials.gov Identifier:	NCT00446563 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Left ventricular hypertrophy, hypertension, valsartan, amlodipine

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Calcium Channel Blockers
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Valsartan
Hypertrophy, Left Ventricular

Losartan
Heart Diseases
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Hypertrophy
Natriuretic Agents
Cardiomegaly
Hypertension

ClinicalTrials.gov processed this record on February 04, 2010