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OpenTrials
Completed

NCT Number: NCT00234871

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

trandolapril/verapamil

Drug

2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD

Other names: ABT-TARKA, Tarka

Lotrel (amlodipine/benazepril)

Drug

5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD

Primary outcomes

  1. Changes in urinary albumin:creatinine ratio

    Time frame: 36 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Acronym: TANDEM

Important dates

Study start
2004
Primary completion
2005
First posted
Oct 10, 2005
Registry last updated
Jul 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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