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Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00139555
First Posted: August 31, 2005
Last Update Posted: February 23, 2017
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
Left ventricular hypertrophy (LVH) increases the risk of cardiovascular morbidity and mortality in patients with high blood pressure, compared to those without LVH. Reduction of left ventricular mass (LVM) with antihypertensive agents is associated with improved clinical outcome. This study will evaluate the effects of amlodipine/benazepril in reducing LVM in patients with high risk hypertension.

Condition Intervention Phase
Hypertension Left Ventricular Hypertrophy Drug: amlodipine/benazepril Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in left ventricular mass index after 52 weeks

Secondary Outcome Measures:
  • Change from baseline in left ventricular mass after 52 weeks
  • Change from baseline in diastolic function after 52 weeks
  • Change from baseline in aorta function assessed blood pressure measurements after 52 weeks
  • Change from baseline in markers of fibrosis and increased heart size after 52 weeks

Enrollment: 125
Study Start Date: July 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or female patients ≥ 55 years of age
  • LVH as confirmed by echocardiogram
  • Patients with high risk hypertension, currently treated or already taking antihypertensive medication

Exclusion Criteria:

  • Renal artery stenosis
  • Symptomatic heart failure or known ejection fraction < 40%
  • Myocardial infarction or stroke within 6 months
  • Presence of cranial aneurysm clips, coronary artery metal stents and pacemakers
  • Pregnant or lactating females
  • Cancer within the last 5 years
  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): NCT00139555


Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00139555     History of Changes
Other Study ID Numbers: CCIB002FUS16
First Submitted: August 29, 2005
First Posted: August 31, 2005
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Hypertension
Left ventricular hypertrophy

Additional relevant MeSH terms:
Hypertension
Hypertrophy
Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Benazepril
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors


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