Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM) (TANDEM)
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|ClinicalTrials.gov Identifier: NCT00234871|
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : July 15, 2008
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|Condition or disease||Intervention/treatment||Phase|
|Hypertension Diabetes Proteinuria||Drug: trandolapril/verapamil Drug: Lotrel (amlodipine/benazepril)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||357 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2004|
|Actual Primary Completion Date :||March 2005|
|Active Comparator: 1||
2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD
|Active Comparator: 2||
Drug: Lotrel (amlodipine/benazepril)
5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD
- Changes in urinary albumin:creatinine ratio [ Time Frame: 36 weeks ]
- 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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234871
|Study Director:||Global Medical Information||Abbott|
|Responsible Party:||Peter Bacher, MD, PhD, Abbott|
|Other Study ID Numbers:||
|First Posted:||October 10, 2005 Key Record Dates|
|Last Update Posted:||July 15, 2008|
|Last Verified:||July 2008|
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