Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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To determine the effect of nebivolol versus metoprolol in Type 2 hypertensive diabetic patients on systolic blood pressure and diastolic blood pressure.

Conditions

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Hypertension Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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nebivolol

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

Group Type EXPERIMENTAL

nebivolol

Intervention Type DRUG

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

Metoprolol

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

Group Type ACTIVE_COMPARATOR

Metoprolol

Intervention Type DRUG

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

Interventions

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nebivolol

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

Intervention Type DRUG

Metoprolol

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

Intervention Type DRUG

Other Intervention Names

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bystolic lopressor

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes