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

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.

Study Type: Interventional

Study Design: Basic Science, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• 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
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Carvedilol CR
• Experimental: Atenolol

Primary Measures

• Central Aortic Blood Pressure
  • Time Frame: Measured at baseline, 2 weeks, and 4 weeks.
    Safety Issue?: No

Secondary Measures

• Peripheral Blood Pressure
  • Time Frame: Measured at baseline, 2 weeks, and 4 weeks.
    Safety Issue?: No

Inclusion Criteria:

• 18-65 years old
• 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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Florida

Overall Clinical Trial Officials and Contacts

Benjamin Epstein, Pharm.D. Principal Investigator University of Florida  

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

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00669279

Study ID Number: 8COG11059

ClinicalTrials.gov Identifier: NCT00669279

Health Authority: United States: Institutional Review Board