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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 11, 2008

Start Date ^ICMJE

January 2004

Primary Completion Date

March 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Changes in urinary albumin:creatinine ratio

Change History

Complete list of historical versions of study NCT00234871 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypertension
Diabetes
Proteinuria

Intervention ^ICMJE

Drug: trandolapril/verapamil
Drug: Lotrel (amlodipine/benazepril)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

357

Completion Date

Primary Completion Date

March 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00234871

Responsible Party

Peter Bacher, MD, PhD, Abbott

Study ID Numbers ^ICMJE

M03-599

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Medical Information

Abbott

Information Provided By

Abbott

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP