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

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

Official Title
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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

Conditions
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Hypertension; Hypertrophy, Left Ventricular

Intervention / Treatment
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* Drug: Valsartan
* Drug: Amlodipine
* Drug: Hydrochlorothiazide
* Drug: Losartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amlodipine + Valsartan<br>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<br>* 160 mg film coated tablets taken orally once daily in the morning.<br>Drug: Amlodipine<br>* 5 mg or 10 mg tablets taken orally once daily in the morning.<br>|
| Active Comparator: Losartan + Hydrochlorothiazide<br>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<br>* 12.5 mg or 25 mg tablets taken orally once daily in the morning.<br>Drug: Losartan<br>* 100 mg tablets taken orally once daily in the morning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI) |  | Baseline to week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI |  | Baseline to week 52 | 
| Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI |  | Baseline to week 52 | 
| Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI |  | Baseline to week 52 | 
| Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI | Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat. | Baseline to week 52 | 
| Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI |  | Baseline to week 52 | 
| Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI |  | Baseline to week 52 | 
| Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI |  | Baseline to week 52 | 
| Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI |  | Baseline to week 52 | 
| Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI |  | Baseline to week 52 | 
| Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI |  | Baseline to week 52 | 
| Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP) |  | Baseline to week 52 | 
| Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP) |  | Baseline to week 52 | 
| Percentage of Participants Achieving Target Blood Pressure at Week 52 | 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. | Week 52 | 
| Percentage of Participants Who Experienced Adverse Events (AEs) | 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. | Baseline to week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left ventricular hypertrophy, hypertension, valsartan, amlodipine