- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00136773
Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
March 8, 2011 updated by: Novartis
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
332
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change from baseline in the urine albumin/creatinine ratio after 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
August 25, 2005
First Submitted That Met QC Criteria
August 25, 2005
First Posted (Estimate)
August 29, 2005
Study Record Updates
Last Update Posted (Estimate)
March 9, 2011
Last Update Submitted That Met QC Criteria
March 8, 2011
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Urologic Diseases
- Urological Manifestations
- Endocrine System Diseases
- Urination Disorders
- Proteinuria
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Albuminuria
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin-Converting Enzyme Inhibitors
- Amlodipine
- Benazepril
Other Study ID Numbers
- CCIB002FUS12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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