Status:
COMPLETED
Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes
Lead Sponsor:
St. Paul Heart Clinic
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Hypertension
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00123604
Start Date
June 1 2004
End Date
June 1 2006
Last Update
November 18 2014
Active Locations (1)
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1
St. Paul Heart Clinic
Saint Paul, Minnesota, United States, 55102