Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00136773
First received: August 25, 2005
Last updated: March 8, 2011
Last verified: March 2008
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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:
Drug Information available for:
Benazepril hydrochloride
Benazepril
Amlodipine
Amlodipine besylate
Lotrel
U.S. FDA Resources
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 (Adult, Senior) |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136773
Sponsors and Collaborators
Novartis
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| 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:
|
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 |
ClinicalTrials.gov processed this record on September 23, 2016