Effect of Carvedilol Controlled-Release (CR) and Atenolol on Central Blood Pressure - Full Text View

Sponsor:	University of Florida
Collaborator:	GlaxoSmithKline
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00669279

Purpose

The purpose of this research study is to determine whether atenolol or controlled release carvedilol lower blood pressure in the body as effectively as in the arm. Blood pressure measured in the aorta, a large blood vessel carrying blood away from the heart, may be a better measure of the harmful effects of high blood pressure on the body's organs. In the past, blood pressure has only been measured in the arms. However, blood pressure in the arms may not accurately reflect the blood pressure in the aorta and thus may mislead doctors treating high blood pressure. For this reason, we are testing whether two different medications for blood pressure, both in a class called beta blockers, have similar effects on blood pressure in the arm and aorta.

Condition	Intervention	Phase
Hypertension	Drug: Carvedilol CR Drug: Atenolol	Phase IV

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Non-Invasive Determination of Central Aortic Blood Pressure in Hypertensive Patients Treated With Controlled-Release Carvedilol or Atenolol

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Atenolol Carvedilol

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

Central Aortic Blood Pressure [ Time Frame: Measured at baseline, 2 weeks, and 4 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Peripheral Blood Pressure [ Time Frame: Measured at baseline, 2 weeks, and 4 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Carvedilol CR: Experimental	Drug: Carvedilol CR Dose titration of 20mg by mouth once daily for 1 week, then 40mg by mouth once daily for 1 week, then 80mg by mouth once daily for 2 weeks
Atenolol: Experimental	Drug: Atenolol Dose titration of 25mg by mouth once daily for 1 week, then 50mg by mouth once daily for 1 week, then 100mg by mouth once daily for 2 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least 18 years of age
Hypertension (untreated or treated with no more then one anti-hypertensive drug)

Exclusion Criteria:

Secondary forms of hypertension (including sleep apnea)
Patients currently treated with two or more antihypertensive drugs
Patients taking antihypertensive drugs with properly measured clinic systolic blood pressure greater then 170mmHg
Isolated systolic hypertension
Other diseases requiring treatment with blood pressure lowering medications
Heart rate less then 55 beats/min (in the absence of beta-blocker therapy)
Known cardiovascular disease including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and TIA)
Known diabetes mellitus (Type 1 or 2)
Renal insufficiency defined as a serum creatinine greater then 1.5mg/dL in males and 1.4mg/dL in females
Primary renal disease
Pregnancy or lactation
History of Raynaud's syndrome
Alcoholism and recreational drug use (due to compliance concerns)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669279

Contacts

Contact: Benjamin Epstein, Pharm.D.	352-273-6232	epstein@cop.ufl.edu
Contact: Gregory Welder	352-273-6180	gwelder@ufl.edu

Locations

United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32610
Contact: Benjamin Epstein, Pharm.D. 352-273-6232 epstein@cop.ufl.edu
Contact: Gregory Welder 352-273-6180 gwstunna@ufl.edu
Principal Investigator: Benjamin Epstein, Pharm.D.
Sub-Investigator: Wilner Nichols, Ph.D.
Sub-Investigator: Issam Zineh, Pharm.D.
Sub-Investigator: Gregory Welder
Sub-Investigator: Umna Ashfaq, M.D.
Sub-Investigator: Priya Satish, M.D.
Sub-Investigator: Margaret C Lo, MD

Sponsors and Collaborators

University of Florida

GlaxoSmithKline

Investigators

Principal Investigator:

Benjamin Epstein, Pharm.D.

University of Florida

More Information

No publications provided

Responsible Party:	University of Florida College of Pharmacy ( Benjamin J. Epstein, Pharm.D., BCPS )
Study ID Numbers:	8COG11059
Study First Received:	April 28, 2008
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00669279 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Sympatholytics
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Vascular Diseases
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Atenolol
Hypertension
Carvedilol

ClinicalTrials.gov processed this record on February 08, 2010