Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00136773
First received: August 25, 2005
Last updated: March 8, 2011
Last verified: March 2008
  Purpose

Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk factor for kidney disease. Aggressive blood pressure reduction is an important strategy to protect the kidney and reduce urinary protein which develops with kidney disease. This study will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary protein in hypertensive subjects with type 2 diabetes mellitus.


Condition Intervention Phase
Albuminuria
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 on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in the urine albumin/creatinine ratio after 52 weeks

Secondary Outcome Measures:
  • Percentage of patients who have progressed to diabetic kidney disease (urine albumin/creatinine ratio ≥ 300 µg/mg creatinine) after 52 weeks
  • Change from baseline in the ratio of urine albumin/creatinine ratio an estimate of kidney function after 52 weeks
  • Change from baseline in insulin resistance after 52 weeks
  • Change from baseline in urine albumin secretion after 52 weeks
  • Change from baseline in a marker of heart failure after 52 weeks

Enrollment: 332
Study Start Date: April 2003
Study Completion Date: November 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Mild to moderate hypertension
  • Type 2 diabetes mellitus
  • Presence of protein in the urine (albuminuria)

Exclusion Criteria:

  • Kidney disease not caused by diabetes or hypertension
  • Renal artery stenosis
  • Myocardial infarction or stroke within the last 6 months
  • Type 1 diabetes mellitus
  • 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: NCT00136773

Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00136773     History of Changes
Other Study ID Numbers: CCIB002FUS12
Study First Received: August 25, 2005
Last Updated: March 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Albuminuria
Type 2 diabetes mellitus
Hypertension

Additional relevant MeSH terms:
Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System 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 August 28, 2014