Status:
COMPLETED
Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Forest Laboratories
Conditions:
Hypertension
Diabetes
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
PHASE3
Brief Summary
The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.
Detailed Description
To determine the effect of nebivolol versus metoprolol in Type 2 hypertensive diabetic patients on systolic blood pressure and diastolic blood pressure.
Eligibility Criteria
Inclusion
- Established Type 2 diabetic not treated with insulin
- Stage 1 hypertensives blood pressure \> 130/80 mmHg and \< 160/100 mmHg
- BMI \< 35
- Hemoglobin A1C \< 8.5
- Must be postmenopausal or taking some form of birth control of surgically sterile
Exclusion
- Acute myocardial infarction, unstable angina, stroke or TIA within the past year.
- Active angina in the last three months
- Diabetes requiring treatment with insulin
- Severe asthma
- Female who are pregnant, planning to be pregnant during the study period, lactating or women of childbearing potential who are not using a medically approved method of contraception
- Recent history of substance or alcohol abuse .
- Uncontrolled hypertension systolic blood pressure \>160mmHg or diastolic blood pressure \> 100 mmHg
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00829296
Start Date
January 1 2009
End Date
April 1 2013
Last Update
February 5 2016
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637