NCT00829296

Brief Summary

The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2 hypertension

Geographic Reach
1 country

1 active site

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

January 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

November 5, 2014

Completed
Last Updated

February 5, 2016

Status Verified

January 1, 2016

Enrollment Period

3.2 years

First QC Date

January 26, 2009

Results QC Date

August 4, 2014

Last Update Submit

January 8, 2016

Conditions

HypertensionDiabetes

Keywords

diabeteshypertensionaortic impedance

Outcome Measures

Primary Outcomes (1)

  • Change in Central Systolic Blood Pressure (SBP)

    Changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in Type 2 hypertensive diabetic patients as measured by the change from baseline in central systolic blood pressure.

    Baseline and 26 Weeks

Secondary Outcomes (3)

  • Change in Pulse Wave Velocity (PWV)

    Baseline and 26 Weeks

  • Change in Augmentation Index

    Baseline and 26 Weeks

  • Change in Pulse Pressure Amplification

    Baseline and 26 Weeks

Study Arms (2)

nebivolol

EXPERIMENTAL

Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached

Drug: nebivolol

Metoprolol

ACTIVE COMPARATOR

Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached

Drug: Metoprolol

Interventions

nebivololDRUG

Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached

Also known as: bystolic
nebivolol
MetoprololDRUG

Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached

Also known as: lopressor
Metoprolol

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Established Type 2 diabetic not treated with insulin
  • Stage 1 hypertensives blood pressure \> 130/80 mmHg and \< 160/100 mmHg
  • BMI \< 35
  • Hemoglobin A1C \< 8.5
  • Must be postmenopausal or taking some form of birth control of surgically sterile

You may not qualify if:

  • Acute myocardial infarction, unstable angina, stroke or TIA within the past year.
  • Active angina in the last three months
  • Diabetes requiring treatment with insulin
  • Severe asthma
  • Female who are pregnant, planning to be pregnant during the study period, lactating or women of childbearing potential who are not using a medically approved method of contraception
  • Recent history of substance or alcohol abuse .
  • Uncontrolled hypertension systolic blood pressure \>160mmHg or diastolic blood pressure \> 100 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

HypertensionDiabetes Mellitus

Interventions

NebivololMetoprolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenoxypropanolaminesPropanolaminesPropanols

Results Point of Contact

Title
Dr. George Bakris
Organization
University of Chicago
gbakris@medicine.bsd.uchicago.edu
773-702-7936

Study Officials

  • George Bakris, M.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

January 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2013

Last Updated

February 5, 2016

Results First Posted

November 5, 2014

Record last verified: 2016-01

Locations

US(1)