Back to resultsTarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM) (TANDEM)
Primary Purpose
Hypertension, Diabetes, Proteinuria
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
trandolapril/verapamil
Lotrel (amlodipine/benazepril)
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Diabetes, Proteinuria, Tarka, Lotrel
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Changes in urinary albumin:creatinine ratio
Secondary Outcome 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00234871
Brief Title
Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)
Acronym
TANDEM
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes, Proteinuria
Keywords
Hypertension, Diabetes, Proteinuria, Tarka, Lotrel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
357 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
trandolapril/verapamil
Other Intervention Name(s)
ABT-TARKA, Tarka
Intervention Description
2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD
Intervention Type
Drug
Intervention Name(s)
Lotrel (amlodipine/benazepril)
Intervention Description
5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD
Primary Outcome Measure Information:
Title
Changes in urinary albumin:creatinine ratio
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information
Organizational Affiliation
Abbott
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)
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