Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM) - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00234871

Purpose

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

Condition	Intervention	Phase
Hypertension Diabetes Proteinuria	Drug: trandolapril/verapamil Drug: Lotrel (amlodipine/benazepril)	Phase IV

MedlinePlus related topics: Diabetes Diabetic Kidney Problems High Blood Pressure

Drug Information available for: Diltiazem Verapamil Dexverapamil Diltiazem hydrochloride Diltiazem malate Verapamil hydrochloride Trandolapril Amlodipine Amlodipine besylate Benazepril Benazepril hydrochloride

U.S. FDA Resources

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

Further study details as provided by Abbott:

Primary Outcome Measures:

Changes in urinary albumin:creatinine ratio [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	357
Study Start Date:	January 2004
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: trandolapril/verapamil 2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD
2: Active Comparator	Drug: Lotrel (amlodipine/benazepril) 5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234871

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Global Medical Information

Abbott

More Information

Responsible Party:	Abbott ( Peter Bacher, MD, PhD )
Study ID Numbers:	M03-599
Study First Received:	September 13, 2005
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00234871
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Hypertension
Diabetes
Proteinuria
Tarka
Lotrel

Study placed in the following topic categories:

Diabetic Nephropathies
Albuminuria
Urination Disorders
Diabetes Mellitus
Vascular Diseases
Amlodipine
Calcium, Dietary
Signs and Symptoms

Proteinuria
Trandolapril
Verapamil
Urologic Diseases
Diltiazem
Benazepril
Kidney Diseases
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Protease Inhibitors
Membrane Transport Modulators
Urological Manifestations
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 16, 2009