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| Sponsor: | State University of New York - Downstate Medical Center |
|---|---|
| Information provided by: | State University of New York - Downstate Medical Center |
| ClinicalTrials.gov Identifier: | NCT00732511 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endothelial Function Diabetes Mellitus Hypertension |
Drug: carvedilol Drug: metoprolol extended release |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | Effect of Coreg CR on BP, Endothelial Function, Exhaled Nitric Oxide, and Nitric Oxide Production and Oxidation |
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Coreg Cr will be up-titrated as needed to achieve blood pressure <130/80
|
Drug: carvedilol
capsules in doses of 20, 40, and 80 mg; once daily; 12 weeks duration
|
|
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
tablets in doses 50, 100, and 200 mg; once daily; 12 weeks duration
|
The following techniques will be used:
Endothelial function will be measured non-invasively by flow-mediated changes in pulsatile blood volume in the finger-tips.
Vascular compliance (stiffness) will be assessed by tonometry of the radial pulse wave ("augmentation index") and diastolic puse wave analysis.
Plasma nitrate/nitrite levels mirror NO production and will be measured spectrophotometrically by the Griess reaction.
Plasma nitrotyrosine, an in vivo marker of NO-dependent damage induced by reactive nitrogen intermediates derived from NO, will be measured by ELISA.
Exhaled NO may provide an real-time measure of endothelial cell NO production and can be measured by a hand-held device which contains an electrochemical detector sensitive to 5 ppb.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nathaniel Winer, M.D. | 718-270-6320 | nathaniel.winer@downstate.edu |
| Contact: Rozina Rana, M.D. | 516-279-8092 | rrana@gmail.com |
| United States, New York | |
| SUNY Downstate Medical Center | Recruiting |
| Brooklyn, New York, United States, 11203 | |
| Contact: Nathaniel Winer, M.D. 718-270-6320 nathaniel.winer@downstate.edu | |
| Contact: Rozina Rana, M.D. 516-279-8092 rrana786@gmail.com | |
| Principal Investigator: | Nathaniel Winer, M.D. | Stae University of New York Downstate Medical Center |
More Information
| Responsible Party: | State University of New York Downstate Medical Center ( Nathaniel Winer, M.D., Principal Investigator ) |
| Study ID Numbers: | Glaxo Smith Kline 111105 |
| Study First Received: | August 11, 2008 |
| Last Updated: | August 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00732511 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Endothelial dysfunction Blood vessel stiffness Nitric oxide Oxidative stress |
|
Respiratory System Agents Neurotransmitter Agents Vasodilator Agents Antioxidants Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Adrenergic beta-Antagonists Cardiovascular Diseases Anti-Arrhythmia Agents Carvedilol Sympatholytics |
Metabolic Diseases Vascular Diseases Diabetes Mellitus Anti-Asthmatic Agents Endocrine System Diseases Adrenergic alpha-Antagonists Cardiovascular Agents Metoprolol Antihypertensive Agents Protective Agents Pharmacologic Actions Nitric Oxide Autonomic Agents Adrenergic Antagonists Peripheral Nervous System Agents |
