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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00139555
First received: August 29, 2005
Last updated: November 7, 2011
Last verified: November 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00139555     History of Changes
Other Study ID Numbers: CCIB002FUS16
Study First Received: August 29, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014