Official Title: “A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Lotrel® on Albuminuria in Hypertensive, Type 2 Diabetic Subjects With Diabetic Nephropathy”

The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2005

Intervention(s) in this Clinical Trial

• Drug: trandolapril/verapamil
  • 2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD
• Drug: Lotrel (amlodipine/benazepril)
  • 5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• Changes in urinary albumin:creatinine ratio
  • Time Frame: 36 weeks
    Safety Issue?: Yes

Secondary Measures

• Changes in blood pressure (BP), BP control, ABPM, proteinuria, GFR lipid parameters, glycemic control, quality of life, CRP, oxidative stress markers, clinical safety labs and adverse events.
  • Time Frame: 36 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Diabetes
• Hypertension
• Albuminuria

Exclusion Criteria:

• Type 1 DM.
• Subject has severe hepatic dysfunction at Screening as determined by liver function tests:
• Bilirubin > 2.0 mg/dL.
• ALT and/or AST > 3 times the upper limit of normal.
• Subject has poorly controlled diabetes, based on HbA1c > 10% at Screening.
• Subject has non-diabetic renal disease.
• Subject has a hypersensitivity to ACE inhibitor, CCB, torsemide or sulfonylureas.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Global Medical Information Study Director Abbott  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00234871

Study ID Number: M03-599

ClinicalTrials.gov Identifier: NCT00234871

Health Authority: United States: Food and Drug Administration