NCT00234871

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357

participants targeted

Target at P50-P75 for phase_4 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
Last Updated

July 15, 2008

Status Verified

July 1, 2008

Enrollment Period

1.2 years

First QC Date

September 13, 2005

Last Update Submit

July 11, 2008

Conditions

HypertensionDiabetesProteinuria

Keywords

HypertensionDiabetesProteinuriaTarkaLotrel

Outcome Measures

Primary Outcomes (1)

  • Changes in urinary albumin:creatinine ratio

    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.

    36 weeks

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: trandolapril/verapamil

2

ACTIVE COMPARATOR
Drug: Lotrel (amlodipine/benazepril)

Interventions

trandolapril/verapamilDRUG

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

Also known as: ABT-TARKA, Tarka
1
Lotrel (amlodipine/benazepril)DRUG

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes
  • Hypertension
  • Albuminuria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionDiabetes MellitusProteinuria

Interventions

trandolaprilVerapamilbenazeprilAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic ChemicalsDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Global Medical Information

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 10, 2005

Study Start

January 1, 2004

Primary Completion

March 1, 2005

Last Updated

July 15, 2008

Record last verified: 2008-07