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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Albuminuria | Drug: amlodipine/benazepril | Phase 4 |
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 |

- Change from baseline in the urine albumin/creatinine ratio after 52 weeks
- 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

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Ages Eligible for Study: | 21 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

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
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00136773 |
Other Study ID Numbers: |
CCIB002FUS12 |
First Posted: | August 29, 2005 Key Record Dates |
Last Update Posted: | March 9, 2011 |
Last Verified: | March 2008 |
Albuminuria Type 2 diabetes mellitus Hypertension |
Albuminuria Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Proteinuria Urination Disorders Urologic Diseases Urological Manifestations Amlodipine |
Benazepril Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |