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

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ClinicalTrials.gov Identifier: NCT00136773
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : March 9, 2011
Sponsor:
Information provided by:
Novartis

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Albuminuria Drug: amlodipine/benazepril Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
Study Start Date : April 2003
Actual Primary Completion Date : October 2005
Actual Study Completion Date : November 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in the urine albumin/creatinine ratio after 52 weeks

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

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00136773


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00136773     History of Changes
Other Study ID Numbers: CCIB002FUS12
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: March 9, 2011
Last Verified: March 2008

Keywords provided by Novartis:
Albuminuria
Type 2 diabetes mellitus
Hypertension

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