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

NCT00669279 | Completed Phase 4 Results

• 1 other identifier: 8COG11059
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Central Aortic Blood Pressure

  Measured at baseline and 4 weeks.

Secondary Outcomes (1)

• Peripheral Blood Pressure

  Measured at baseline, 2 weeks, and 4 weeks.

Study Arms (2)

Carvedilol CR

EXPERIMENTAL

Drug: Carvedilol CR

Atenolol

EXPERIMENTAL

Drug: Atenolol

Interventions

Carvedilol CR 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

Also known as: Coreg CR

Carvedilol CR

Atenolol 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

Also known as: Tenormin

Atenolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Hypertension (untreated or treated with no more then one anti-hypertensive drug)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Carvedilol; Atenolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Phenoxypropanolamines

Limitations and Caveats

Small sample size, short duration.

Results Point of Contact

• Title: Dr. Benjamin J Epstein
• Organization: University of Florida

epstein@cop.ufl.edu

3523590945

Study Officials

• Benjamin Epstein, Pharm.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2008
• First Posted: April 30, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 5, 2017
• Results First Posted: March 23, 2012

Record last verified: 2017-09

Locations

US (1)