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

Primary Purpose

Albuminuria

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
amlodipine/benazepril
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Albuminuria focused on measuring Albuminuria, Type 2 diabetes mellitus, Hypertension

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    August 25, 2005
    Last Updated
    March 8, 2011
    Sponsor
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00136773
    Brief Title
    Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
    Official Title
    Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2003 (undefined)
    Primary Completion Date
    October 2005 (Actual)
    Study Completion Date
    November 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Novartis

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Albuminuria
    Keywords
    Albuminuria, Type 2 diabetes mellitus, Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    332 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    amlodipine/benazepril
    Primary Outcome Measure Information:
    Title
    Change from baseline in the urine albumin/creatinine ratio after 52 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage of patients who have progressed to diabetic kidney disease (urine albumin/creatinine ratio ≥ 300 µg/mg creatinine) after 52 weeks
    Title
    Change from baseline in the ratio of urine albumin/creatinine ratio an estimate of kidney function after 52 weeks
    Title
    Change from baseline in insulin resistance after 52 weeks
    Title
    Change from baseline in urine albumin secretion after 52 weeks
    Title
    Change from baseline in a marker of heart failure after 52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    85 Years
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

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

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