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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

Primary Purpose

Hypertension; Hypertrophy, Left Ventricular

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Valsartan
Amlodipine
Hydrochlorothiazide
Losartan
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension; Hypertrophy, Left Ventricular focused on measuring Left ventricular hypertrophy, hypertension, valsartan, amlodipine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 25 centers in Germany

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amlodipine + Valsartan

Losartan + Hydrochlorothiazide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)

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
Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI
Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI
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.
Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI
Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI
Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI
Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI
Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)
Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)
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.
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.

Full Information

First Posted
March 12, 2007
Last Updated
May 6, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00446563
Brief Title
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

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension; Hypertrophy, Left Ventricular
Keywords
Left ventricular hypertrophy, hypertension, valsartan, amlodipine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amlodipine + Valsartan
Arm Type
Experimental
Arm Description
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.
Arm Title
Losartan + Hydrochlorothiazide
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Valsartan
Intervention Description
160 mg film coated tablets taken orally once daily in the morning.
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
5 mg or 10 mg tablets taken orally once daily in the morning.
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide
Intervention Description
12.5 mg or 25 mg tablets taken orally once daily in the morning.
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
100 mg tablets taken orally once daily in the morning.
Primary Outcome Measure Information:
Title
Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)
Time Frame
Baseline to week 52
Secondary Outcome Measure Information:
Title
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
Title
Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI
Time Frame
Baseline to week 52
Title
Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI
Time Frame
Baseline to week 52
Title
Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI
Description
Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.
Time Frame
Baseline to week 52
Title
Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI
Time Frame
Baseline to week 52
Title
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
Title
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI
Time Frame
Baseline to week 52
Title
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
Title
Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI
Time Frame
Baseline to week 52
Title
Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI
Time Frame
Baseline to week 52
Title
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
Title
Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)
Time Frame
Baseline to week 52
Title
Percentage of Participants Achieving Target Blood Pressure at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Participants Who Experienced Adverse Events (AEs)
Description
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.
Time Frame
Baseline to week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
25 centers in Germany
City
Ludwigshafen
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27536421
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.
Results Reference
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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

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