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”

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

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.

Primary Measures

• Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)
  • Time Frame: Baseline to week 52
    Safety Issue?: No

Secondary 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
    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
    Safety Issue?: No
• Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI
  • Time Frame: Baseline to week 52
    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
    Safety Issue?: No
• Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI
  • Time Frame: Baseline to week 52
    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
    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
    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
    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
    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
    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
    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
    Safety Issue?: No
• Percentage of Participants Achieving Target Blood Pressure at Week 52
  • Time Frame: Week 52
    Safety Issue?: No
• Percentage of Participants Who Experienced Adverse Events (AEs)
  • Time Frame: Baseline to week 52
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Study Chair Novartis  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00446563

Study ID Number: CVAA489ADE02

ClinicalTrials.gov Identifier: NCT00446563

Health Authority: Germany: Federal Institute for Drugs and Medical Devices