Clinical trial NCT00446563: Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension; Hypertrophy, Left Ventricular
Keywords: Left ventricular hypertrophy, hypertension, valsartan, amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-03-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 \<= 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

Primary outcomes:
measure: Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)
timeFrame: Baseline to week 52
Secondary outcomes:
measure: Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI
timeFrame: Baseline to week 52
measure: Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI
timeFrame: Baseline to week 52
measure: Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI
timeFrame: Baseline to week 52
measure: Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI
timeFrame: Baseline to week 52
measure: Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI
timeFrame: Baseline to week 52
measure: Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI
timeFrame: Baseline to week 52
measure: Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI
timeFrame: Baseline to week 52
measure: Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI
timeFrame: Baseline to week 52
measure: Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI
timeFrame: Baseline to week 52
measure: Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI
timeFrame: Baseline to week 52
measure: Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)
timeFrame: Baseline to week 52
measure: Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)
timeFrame: Baseline to week 52
measure: Percentage of Participants Achieving Target Blood Pressure at Week 52
timeFrame: Week 52
measure: Percentage of Participants Who Experienced Adverse Events (AEs)
timeFrame: Baseline to week 52
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: 25 centers in Germany
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: Bruder O, Jensen CJ, Bell M, Rummel R, Boehm G, Klebs S, Sieder C, Senges J. Effects of the combinations of amlodipine/valsartan versus losartan/hydrochlorothiazide on left ventricular hypertrophy as determined with magnetic resonance imaging in patients with hypertension. J Drug Assess. 2011 Dec 16;1(1):1-10. doi: 10.3109/21556660.2011.639418. eCollection 2012.