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

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University of Florida

Status and phase

Completed
Phase 4

Conditions

Hypertension

Treatments

Drug: Carvedilol CR
Drug: Atenolol

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00669279
8COG11059

Details and patient eligibility

About

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.

Full description

Carvedilol reduces aortic wave reflection and improves left ventricular/vascular coupling: a comparison with atenolol (CENTRAL Study) is a prospective, open-label, comparative, randomized control trial that evaluated brachial and central hemodynamic profiles in patients taking atenolol or controlled-release carvedilol.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

41 participants in 2 patient groups

Carvedilol CR
Experimental group
Treatment:
Drug: Carvedilol CR
Atenolol
Experimental group
Treatment:
Drug: Atenolol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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