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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Kidney Problems High Blood Pressure

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

U.S. FDA Resources

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
Active Comparator: 1	Drug: trandolapril/verapamil 2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD Other Names: ABT-TARKA trandolapril/verapamil Tarka
Active Comparator: 2	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

No publications provided

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

Keywords provided by Abbott:

Hypertension
Diabetes
Proteinuria
Tarka
Lotrel

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetic Nephropathies
Hypertension
Proteinuria
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Diabetes Complications
Vascular Diseases
Cardiovascular Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms

Verapamil
Diltiazem
Amlodipine
Benazepril
Trandolapril
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 13, 2012