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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome: Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline to week 52 ]

Original Primary Outcome: To compare the combination of valsartan 160mg and amlodipine 5mg with the combination of losartan 100mg and HCTZ 12.5mg with regard to regression of left ventricular hypertrophy (echo) after 12 months of treatment

Current Secondary Outcome:

  • 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 ]
  • Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI [ Time Frame: Baseline to week 52 ]
  • Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI [ Time Frame: Baseline to week 52 ]
  • Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI [ Time Frame: Baseline to week 52 ]
    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 ]
  • 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 ]
  • Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI [ Time Frame: 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 [ Time Frame: Baseline to week 52 ]
  • Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI [ Time Frame: Baseline to week 52 ]
  • Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI [ Time Frame: Baseline to week 52 ]
  • 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 ]
  • Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: Baseline to week 52 ]
  • Percentage of Participants Achieving Target Blood Pressure at Week 52 [ Time Frame: 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.
  • Percentage of Participants Who Experienced Adverse Events (AEs) [ Time Frame: Baseline to week 52 ]
    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.


Original Secondary Outcome:

  • To compare the combination of val 160mg and aml 5mg with the combination of losartan 100mg and HCTZ 12.5mg with regard to a change in parameters such as left ventricular wall thickness, left ventricular ejection fraction, left ventricular end
  • To compare the combination of val 160mg and aml 5mg with the combination of losartan 100mg and HCTZ 12.5mg with regard to the impact of both combinations on the change in NT-proBNP and High-Sensitivity C-Reactive Protein.
  • To evaluate the overall safety and tolerability of the combination of val 160mg and aml5mg compared with the combination of losartan 100mg and HCTZ 12.5mg in patients with essential hypertension and left ventricular hypertrophy


Information By: Novartis

Dates:
Date Received: March 12, 2007
Date Started: March 2007
Date Completion:
Last Updated: May 6, 2011
Last Verified: May 2011