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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00669279
First received: April 28, 2008
Last updated: February 17, 2012
Last verified: September 2011
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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:

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 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 ]

Enrollment: 41
Study Start Date: April 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carvedilol CR 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
Other Name: Coreg CR
Experimental: Atenolol 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
Other Name: Tenormin

Detailed 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.

  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

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
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
ClinicalTrials.gov Identifier: NCT00669279     History of Changes
Other Study ID Numbers: 8COG11059
Study First Received: April 28, 2008
Results First Received: December 5, 2011
Last Updated: February 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Atenolol
Carvedilol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on May 22, 2013