NCT00234858

Brief Summary

The primary objective of this study is to determine whether impaired glucose tolerance is improved to a greater degree by Tarka than Hyzaar in subjects with metabolic syndrome

Trial Health

100
On Track

Trial Health Score

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

Enrollment
280

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years 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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Last Updated

July 15, 2008

Status Verified

June 1, 2008

Enrollment Period

2.1 years

First QC Date

September 13, 2005

Last Update Submit

July 11, 2008

Conditions

HypertensionMetabolic Syndrome

Keywords

HypertensionMetabolic SyndromeTarkaHyzaar

Outcome Measures

Primary Outcomes (1)

  • Oral Glucose Tolerance

    up to 1 year / 52 weeks

Secondary Outcomes (1)

  • Changes in blood pressure (BP), pulse rate and BP control. HbA1c, insulin sensitivity, insulin release, albuminuria, lipid profile, AMBP, clinical safety labs and adverse events.

    up to 1 year / 52 weeks

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: trandolapril/verapamil

2

ACTIVE COMPARATOR
Drug: (Hyzaar) losartan/hydrochlorothiazide

Interventions

trandolapril/verapamilDRUG

2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD

Also known as: ABT-TARKA, Tarka
1
(Hyzaar) losartan/hydrochlorothiazideDRUG

50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD

Also known as: Hyzaar, losartan/hydrochlorothiazide
2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metabolic syndrome
  • Fasting blood glucose between 100 mg/dL and 125 mg/dL
  • Hypertension

You may not qualify if:

  • Subject has a current diagnosis of Type 1 or Type 2 diabetes mellitus.
  • Subject has a hypersensitivity to ACE inhibitor, ARB, CCB, clonidine, methyldopa, hydralazine, or thiazide diuretic medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bakris G, Molitch M, Hewkin A, Kipnes M, Sarafidis P, Fakouhi K, Bacher P, Sowers J; STAR Investigators. Differences in glucose tolerance between fixed-dose antihypertensive drug combinations in people with metabolic syndrome. Diabetes Care. 2006 Dec;29(12):2592-7. doi: 10.2337/dc06-1373.

    PMID: 17130190DERIVED

MeSH Terms

Conditions

HypertensionMetabolic Syndrome

Interventions

trandolaprilVerapamilhydrochlorothiazide, losartan drug combinationLosartanHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic ChemicalsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

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

March 1, 2004

Primary Completion

April 1, 2006

Last Updated

July 15, 2008

Record last verified: 2008-06