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

Information source: University of Florida
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Carvedilol CR (Drug); Atenolol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Florida

Official(s) and/or principal investigator(s):
Benjamin Epstein, Pharm.D., Principal Investigator, Affiliation: University of Florida

Overall contact:
Benjamin Epstein, Pharm.D., Phone: 352-273-6232, Email: epstein@cop.ufl.edu

Summary

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.

Clinical Details

Official title: Non-Invasive Determination of Central Aortic Blood Pressure in Hypertensive Patients Treated With Controlled-Release Carvedilol or Atenolol

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Central Aortic Blood Pressure

Secondary outcome: Peripheral Blood Pressure

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Benjamin Epstein, Pharm.D., Phone: 352-273-6232, Email: epstein@cop.ufl.edu

University of Florida, Gainesville, Florida 32610, United States; Recruiting
Benjamin Epstein, Pharm.D., Phone: 352-273-6232, Email: epstein@cop.ufl.edu
Gregory Welder, Phone: 352-273-6446, Email: gwelder@ufl.edu
Benjamin Epstein, Pharm.D., Principal 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, Sub-Investigator
Additional Information

Starting date: April 2008
Last updated: February 19, 2010

Page last updated: October 04, 2010

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