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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00446563
First Posted: March 13, 2007
Last Update Posted: May 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy

Condition Intervention Phase
Hypertension; Hypertrophy, Left Ventricular Drug: Valsartan Drug: Amlodipine Drug: Hydrochlorothiazide Drug: Losartan Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome 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 ]
  • 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.


Enrollment: 90
Study Start Date: March 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446563


Locations
Germany
25 centers in Germany
Ludwigshafen, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00446563     History of Changes
Other Study ID Numbers: CVAA489ADE02
First Submitted: March 12, 2007
First Posted: March 13, 2007
Results First Submitted: March 31, 2011
Results First Posted: April 27, 2011
Last Update Posted: May 11, 2011
Last Verified: May 2011

Keywords provided by Novartis:
Left ventricular hypertrophy, hypertension, valsartan, amlodipine

Additional relevant MeSH terms:
Hypertension
Hypertrophy
Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Amlodipine
Valsartan
Hydrochlorothiazide
Losartan
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Anti-Arrhythmia Agents