Skip to main content
OpenTrials
Completed

NCT Number: NCT00123604

Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes

The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Paul Heart Clinic

Saint Paul, Minnesota, 55102, United States

About this study

Carvedilol and metoprolol are two commonly used blood pressure medications that have both been shown to be effective in controlling hypertension. Although in the same drug class, preliminary data have shown that these medications may have different vascular effects. This study will assess which medication is better at improving artery health independent of their blood pressure lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 30-80 years old
  • Documented history of type 2 diabetes
  • Stable angiotensin converting enzyme/angiotensin receptor blocker (ACE/ARB) regimen 30 days before and throughout the study period
  • Stable anti-diabetic regimen throughout the study period
  • Body mass index (BMI) between 22-45 kg/m2
  • HbA1c between 6-9% for patients on anti-diabetic treatment regimen and HbA1c between 6-8% for patients who are being controlled by diet alone
  • Screening blood pressure (BP) > 130/80 (average of 3 sitting measurements), with current medications

Exclusion criteria

  • Uncontrollable or symptomatic arrhythmias
  • Unstable angina
  • Sick sinus syndrome or second or third degree heart block
  • Decompensated heart failure
  • Myocardial infarction (MI) or stroke within 3 months of screening
  • Bradycardia
  • Chronic obstructive pulmonary disease (COPD) with required inhaled or oral bronchodilators or corticosteroids
  • Bronchial asthma or related bronchospastic conditions
  • New onset/diagnosed type 2 diabetes (<3 months)
  • Clinically significant renal or liver disease (creatinine >2.5 mg/dL)
  • Endocrine disorders
  • Use of anorectic or other diet drugs inconsistent with recommendations for type 2 diabetics
  • Use of beta-blockers within 3 months of screening
  • Use of corticosteroids
  • Systemic disease, including cancer, with reduced life expectancy (<12 months)
  • Psychological illness/condition that interferes with comprehension of study requirements
  • Use of an investigational drug within 30 days of entry into study

Treatment and study plan

Carvedilol

Drug

25 mg twice daily for five months.

Other names: Coreg

metoprolol

Drug

200 mg twice daily for five months.

Other names: Lopressor

Primary outcomes

  1. Flow Mediated Dilation

    Time frame: change from baseline to 5 months

    Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion.

Sponsors and collaborators

Lead sponsor

St. Paul Heart Clinic

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Effects of Carvedilol and Metoprolol on Endothelial Function in Hypertensive Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jul 25, 2005
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.