Coreg CR, Blood Vessel Stiffness and Blood Vessel Function

NCT00732511 | Unknown Phase 4

• 1 other identifier: Glaxo Smith Kline 111105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

We are comparing the blood pressure-lowering effects of two marketed medications, Coreg CR and Toprol XL. Although both drugs reduce blood pressure by blocking the action of noradrenaline on beta-receptors in the blood vessels, Coreg CR also blocks alpha-receptors, which may provide added blood pressure-lowering. In addition, Coreg CR may have anti-oxidant actions. Cells which line blood vessels (termed "endothelial cells") make nitric oxide (NO), which relaxes the muscle cells encircling the blood vessels, causing a reduction in blood pressure. When body cells use oxygen, they normally produce "free radicals", which can destroy NO,leading to high blood pressure, heart damage and worsenimg of diabetes. Antioxidants remove free radicals and prevent or repair this damage. In this study we will measure endothelial cell function, blood vessel wall stiffness, NO in exhaled breath, and blood levels of substances which reflect NO production and destruction to determine if a pure beta-blocker (Toprol XL) differs from an alpha/beta blocker (Coreg CR) in these effects. We will also examine the mechanism by which such differences might occur.

Conditions

Endothelial Function; Diabetes Mellitus; Hypertension

Keywords

Endothelial dysfunction; Blood vessel stiffness; Nitric oxide; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• Effect of Coreg CR compared to Toprol XL on endothelial function, vascular compliance, and parameters of oxidative stress from time of randomization to study drug termination

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Coreg Cr will be up-titrated as needed to achieve blood pressure \<130/80

Drug: carvedilol

2

ACTIVE COMPARATOR

Toprol XL will be up-titrated at weekly intervals to achieve a blood pressure \<130/80 mm Hg

Drug: metoprolol extended release

Interventions

carvedilol DRUG

capsules in doses of 20, 40, and 80 mg; once daily; 12 weeks duration

Also known as: Coreg CR

1

metoprolol extended release DRUG

tablets in doses 50, 100, and 200 mg; once daily; 12 weeks duration

Also known as: Toprol XL

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus,
• Stable antidiabetic regimen for 3 months
• Hemoglobin A1c \<8.6%
• Stable antihypertensive medication regimen for 3 months or more, including either an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker

You may not qualify if:

• Any clinically significant abnormality on history, physical examination, or laboratory testing which could preclude safe completion of the study
• Significant cardiac conditions
• Lung disease
• Cigarette smoking
• Chronic kidney disease (Stage 3 or greater)
• Type 1 diabetes
• Known contraindication to alpha- or beta-blocker therapy

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Interventions

Carvedilol; Metoprolol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Phenoxypropanolamines

Study Officials

• Nathaniel Winer, M.D.

  Stae University of New York Downstate Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathaniel Winer, M.D.

CONTACT

718-270-6320; nathaniel.winer@downstate.edu

Rozina Rana, M.D.

CONTACT

516-279-8092; rrana@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 12, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: April 1, 2009
• Last Updated: February 10, 2011

Record last verified: 2011-02

Locations

US (1)