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NCT00744237

Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients

Last Updated: 2011-07-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Brief Summary

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This study will evaluate the effects of nebivolol on glycemic control compared with metoprolol and HCTZ in patients with hypertension and type 2 diabetes mellitus

Detailed Description

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Conditions

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Hypertension Type 2 Diabetes Mellitus

Keywords

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nebivolol Bystolic ™ Hypertension Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

* Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration
* Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration
* Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration
* Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration
* Open-label amlodipine may be given

Group Type EXPERIMENTAL

Nebivolol

Intervention Type DRUG

2

* Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration
* Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration
* Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration
* Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration
* Open-label amlodipine may be given

Group Type ACTIVE_COMPARATOR

Metoprolol ER

Intervention Type DRUG

3

* HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
* HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
* Open-label amlodipine may be given

Group Type ACTIVE_COMPARATOR

HCTZ

Intervention Type DRUG

* HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
* HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration

Interventions

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Nebivolol

Intervention Type DRUG

Metoprolol ER

Intervention Type DRUG

HCTZ

* HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
* HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration

Intervention Type DRUG

Other Intervention Names

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Bystolic (TM) Hydrochlorothorazide

Eligibility Criteria

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Inclusion Criteria

* Male or female, 18-85 years of age
* Blood pressure in the range of 130 to 179/80 to 109 mmHg
* Currently using either an ACE inhibitor or an ARB alone or (an ACE inhibitor or an ARB and up to two other drugs for treatment of high blood pressure). (Patients may be on both an ACE inhibitor and ARB, but would need to be taken off one.)
* Stable medication regimen for high blood pressure for at least one month prior to screening
* Stable type 2 diabetes mellitus for at least 3 months prior to screening that is controlled by any or all of the following: diet and antidiabetic medications that may include fixed-dose insulin
* HgbA1c 6.5 to 8.5% (This is measured at the screening visit)

Exclusion Criteria

* Use of any beta blocker within one month prior to screening
* Use of clonidine within 3 months prior to screening
* Diagnosis of hyperthyroidism as evidenced by abnormal lab markers
* Any disorder requiring the intermittent or chronic use of systemic corticosteroids
* Diagnosis of hyperthyroidism as determined by lab markers done at screening
* Active liver disease as determined by lab markers
* Kidney impairment; estimated GFR \< 60 mL/min/1.73 m2
* History of heart attack, clinically significant arrhythmia, unstable angina, coronary angioplasty/bypass surgery, stroke, or TIA in 3 months prior to screening
* Chronic heart failure
* Drug or alcohol abuse within 2 years prior to screening
* History of sensitivity to any beta blocker, HCTZ, sulfa drug, or calcium channel blocker
* Participation in another research study within 30 days prior to screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Forest Research Institute, a Subsidiary of Forest Laboratories Inc.

Principal Investigators

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John Shea, MS

Role: STUDY_DIRECTOR

Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.

Salinas, , Puerto Rico

Site Status

Forest Investigative Site 29

Santurce, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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NEB-MD-19

Identifier Type: -

Identifier Source: org_study_id

Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

Nebivolol

2

Metoprolol ER

3

HCTZ

Interventions

Nebivolol

Metoprolol ER

HCTZ

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Forest Laboratories

Responsible Party

Principal Investigators

John Shea, MS

Locations

Forest Investigative Site 15

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