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

NCT ID: NCT00669279

Last Updated: 2017-10-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Carvedilol CR

Group Type EXPERIMENTAL

Carvedilol CR

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Atenolol

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Coreg CR Tenormin

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Epstein, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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8COG11059

Identifier Type: -

Identifier Source: org_study_id