Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects Wit... | NCT00234871

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

NCT00234871

Sponsor

Abbott

Status

Completed

Last Update Posted

Jul 15, 2008Estimated

Enrollment

357Actual

Phase

Phase 4

Conditions

Hypertension
Diabetes
Proteinuria

Interventions

trandolapril/verapamil
Lotrel (amlodipine/benazepril)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Mar 2005Actual

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Oct 7, 2005

First Posted Date

Oct 10, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2008

Last Update Posted Date

Jul 15, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

357Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: trandolapril/verapamil
2	Active Comparator		Drug: Lotrel (amlodipine/benazepril)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
trandolapril/verapamil	Drug	2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in urinary albumin:creatinine ratio		36 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.		36 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Global Medical Information	Abbott	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D003920	Diabetes Mellitus
D011507	Proteinuria

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C052035	trandolapril
D014700	Verapamil
C044946	benazepril
D017311	Amlodipine

Ancestor Terms

ID	Term
D010627	Phenethylamines
D005021	Ethylamines
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided