Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)
Phase 4
Completed
- Conditions
- HypertensionDiabetesProteinuria
- Interventions
- Drug: trandolapril/verapamil
- Registration Number
- NCT00234871
- Lead Sponsor
- Abbott
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 357
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 trandolapril/verapamil - 2 Lotrel (amlodipine/benazepril) -
- Primary Outcome Measures
Name Time Method Changes in urinary albumin:creatinine ratio 36 weeks
- Secondary Outcome Measures
Name Time Method 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. 36 weeks