Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
St. Paul Heart Clinic
Collaborator:
GlaxoSmithKline
Information provided by:
St. Paul Heart Clinic
ClinicalTrials.gov Identifier:
NCT00123604
First received: July 21, 2005
Last updated: April 10, 2007
Last verified: April 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Type 2 Diabetes Mellitus |
Drug: carvedilol Drug: metoprolol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Effects of Carvedilol and Metoprolol on Endothelial Function in Hypertensive Patients With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Drug Information available for:
Metoprolol
Metoprolol tartrate
Carvedilol
Metoprolol succinate
Metoprolol fumarate
U.S. FDA Resources
Further study details as provided by St. Paul Heart Clinic:
Primary Outcome Measures:
- Improvement in endothelial function
Secondary Outcome Measures:
- Improvement in markers of inflammation and oxidative stress
| Estimated Enrollment: | 36 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | February 2006 |
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.
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123604
Locations
| United States, Minnesota | |
| St. Paul Heart Clinic | |
| St. Paul, Minnesota, United States, 55102 | |
Sponsors and Collaborators
St. Paul Heart Clinic
GlaxoSmithKline
Investigators
| Principal Investigator: | Alan J Bank, M.D. | St. Paul Heart Clinic |
More Information
No publications provided by St. Paul Heart Clinic
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00123604 History of Changes |
| Other Study ID Numbers: | GSK101598 |
| Study First Received: | July 21, 2005 |
| Last Updated: | April 10, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by St. Paul Heart Clinic:
|
beta-blockers endothelial function |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Hypertension Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Metoprolol Carvedilol Metoprolol succinate 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 21, 2013