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: Valsartan Drug: Amlodipine Drug: Hydrochlorothiazide Drug: Losartan	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:

Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.
Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP) [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
Percentage of Participants Achieving Target Blood Pressure at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Target blood pressure defined as having a mean sitting systolic blood pressure (MSSBP) < 140 mm Hg and a mean sitting diastolic blood pressure (MSDBP) < 90 mm Hg.
Percentage of Participants Who Experienced Adverse Events (AEs) [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: Yes ]
An adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after obtaining informed consent even if the event was not considered to be related to study drug. Medical conditions/diseases present before obtaining informed consent were only considered adverse events if they worsened after study start. Abnormal laboratory values or test results constituted adverse events only if they induced clinical signs or symptoms, required study drug discontinuation or required therapy.

Enrollment:	90
Study Start Date:	March 2007
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Amlodipine + Valsartan 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.	Drug: Valsartan 160 mg film coated tablets taken orally once daily in the morning. Drug: Amlodipine 5 mg or 10 mg tablets taken orally once daily in the morning.
Active Comparator: Losartan + Hydrochlorothiazide 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.	Drug: Hydrochlorothiazide 12.5 mg or 25 mg tablets taken orally once daily in the morning. Drug: Losartan 100 mg tablets taken orally once daily in the morning.

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

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00446563 History of Changes
Other Study ID Numbers:	CVAA489ADE02
Study First Received:	March 12, 2007
Results First Received:	March 31, 2011
Last Updated:	May 6, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Left ventricular hypertrophy, hypertension, valsartan, amlodipine

Additional relevant MeSH terms:

Hypertension
Hypertrophy
Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Hydrochlorothiazide
Valsartan
Amlodipine
Losartan
Diuretics
Natriuretic Agents

Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012