NCT01271374

Brief Summary

The purpose of the study is to compare the effects of Azor (a combination of amlodipine and olmesartan) with Hyzaar ( a combination of losartan and hydrochlorothiazide) on the thin lining on the inside of blood vessels. These cells help keep blood vessels healthy and blood pressure normal.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 5, 2011

Status Verified

May 1, 2011

Enrollment Period

1.2 years

First QC Date

January 5, 2011

Last Update Submit

May 4, 2011

Conditions

Hypertension

Keywords

African AmericanHypertensionCardiometabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in Central Aortic Pressure (CAP)

    The primary efficacy endpoints, defined as the change from baseline of Central Aortic Systolic Pressure (CAP) and the change in brachial artery reactivity (BART) via ultrasound testing, will be compared at the end of 14 weeks of randomized treatment.

    14 weeks

Secondary Outcomes (1)

  • Blood pressure control

    25 weeks

Study Arms (2)

Hyzaar-Treatment Arm B

ACTIVE COMPARATOR

Weeks 1-2: Hyzaar® 50/12.5 Weeks 3-14: Hyzaar® 100/25 Weeks 15-18: Azor® 10/40+HCTZ 25 Weeks 19-20: Azor® 10/40+HCTZ 25 + spironolactone 25 once daily

Drug: losartan and HCTZ

Azor-Treatment A

ACTIVE COMPARATOR

Weeks 1-2: Azor® 5/20 Weeks 3-14: Azor® 10/40 Weeks 15-18: Azor® 10/40+HCTZ 25 Weeks 19-20: Azor® 10/40+HCTZ 25 + spironolactone 25 once daily

Drug: amlodipine and olmesartan

Interventions

amlodipine and olmesartanDRUG

Weeks 1-2: Azor® 5/20 Weeks 3-14: Azor® 10/40 Weeks 15-18: Azor® 10/40+HCTZ 25 Weeks 19-20: Azor® 10/40+HCTZ 25 + spironolactone 25 once daily

Also known as: Azor, Hydrochlorothiazide, Spironoloactone
Azor-Treatment A
losartan and HCTZDRUG

Weeks 1-2: Hyzaar® 50/12.5 Weeks 3-14: Hyzaar® 100/25 Weeks 15-18: Azor® 10/40+HCTZ 25 Weeks 19-20: Azor® 10/40+HCTZ 25 + spironolactone 25 once daily

Also known as: Hyzaar, Azor, Hydrochlorothiazide, Spironolactone
Hyzaar-Treatment Arm B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American
  • Hypertension and one of the following:
  • Fasting glucose \> 100 mg/dl
  • HgA1C\> 6.0 %
  • Plasma triglycerides \>150
  • HDL cholesterol \< 40 mg/dl in men or \< 50 mg/dl in women

You may not qualify if:

  • History of Heart failure
  • use of insulin
  • non-dominant arm circ \> 50 cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta Clinical Research Center

Tucker, Georgia, 30084, United States

Location

MeSH Terms

Conditions

HypertensionMetabolic Syndrome

Interventions

Amlodipine Besylate, Olmesartan Medoxomil Drug CombinationHydrochlorothiazideLosartanhydrochlorothiazide, losartan drug combinationSpironolactone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Olmesartan MedoxomilImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesAmlodipineDihydropyridinesPyridinesDrug CombinationsPharmaceutical PreparationsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsLactonesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Bobby V Khan, MD, PhD

    Director, Atlanta Clinical Research Centers

    PRINCIPAL INVESTIGATOR

  • Keith C Ferdinand, MD

    Atlanta Clinical Research Centers

    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

January 5, 2011

First Posted

January 6, 2011

Study Start

April 1, 2010

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

May 5, 2011

Record last verified: 2011-05

Locations

US(1)