Phase 3 N=90 Randomized Treatment

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

Hypertension; Hypertrophy, Left Ventricular

Bottom Line

View on ClinicalTrials.gov: NCT00446563 ↗

Enrolled (actual)

Serious AEs

8.9%

Results posted

Apr 2011

Primary outcome: Primary: Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI) — -7.1; -9.1 g/m˄2

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Valsartan (Drug); Amlodipine (Drug); Hydrochlorothiazide (Drug); Losartan (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)	-7.1; -9.1	—
SECONDARY Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI	-3.5; -4.4	—
SECONDARY Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI	-1.1; -0.6	—
SECONDARY Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI	-0.4; -0.3	—
SECONDARY Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI	-0.8; -0.4	—
SECONDARY Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI	0.1; -6.4	—
SECONDARY Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI	0.0; -3.0	—
SECONDARY Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI	0.4; -1.5	—
SECONDARY Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI	0.2; -0.8	—
SECONDARY Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI	-0.6; -1.0	—
SECONDARY Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI	0.1; -0.8	—
SECONDARY Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)	-4.5; -40.1	—
SECONDARY Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)	0.8; -2.1	—
SECONDARY Percentage of Participants Achieving Target Blood Pressure at Week 52	53.5; 14.9	—
SECONDARY Percentage of Participants Who Experienced Adverse Events (AEs)	69.8; 68.1	—

Summary

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

Eligibility 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 =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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00446563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.