Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00136773

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 High Blood Pressure Urine and Urination

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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136773

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

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:

Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Amlodipine

Benazepril
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012