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

• ClinicalTrials.gov Identifier: NCT00136773
• Recruitment Status: Completed
• First Posted: August 29, 2005
• Last Update Posted: March 9, 2011
• Sponsor: Novartis
• Information provided by: Novartis

Tracking Information

• First Submitted Date: August 25, 2005
• First Posted Date: August 29, 2005
• Last Update Posted Date: March 9, 2011
• Study Start Date: April 2003
• Actual Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 1, 2006): Change from baseline in the urine albumin/creatinine ratio after 52 weeks
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: June 1, 2006)

• 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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Albuminuria
• Intervention: Drug: amlodipine/benazepril
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 8, 2011): 332
• Original Enrollment: Not Provided
• Actual Study Completion Date: November 2005
• Actual Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00136773
• Other Study ID Numbers: CCIB002FUS12
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Novartis
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: March 2008