Status:
COMPLETED
Comparison of 2 Beta Blocker Drugs on Peripheral Arterial Disease in Patients With High Blood Pressure
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Forest Laboratories
Conditions:
Peripheral Artery Disease
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a 26-week, prospective double-blind, randomized pilot trial of nebivolol versus an active control, metoprolol succinate, in patients with established lower-extremity peripheral artery disease,...
Detailed Description
Peripheral arterial disease (PAD) affects up to an estimated 16-29% of men and women over age 50, and is associated with increased cardiovascular morbidity and mortality. Beta-blockers have been shown...
Eligibility Criteria
Inclusion
- Men and non-pregnant, non-lactating women 45 years of age or older
- Able to give informed consent and complete scheduled visits
- Mild-moderate bilateral lower extremity peripheral arterial disease as defined by an ankle-brachial index (ABI measurement of 0.6-0.9. If a subject has baseline claudication symptoms, the symptoms must be stable for the 3 months preceding enrollment.
- History of hypertension. Blood pressure at the screening visit must be ≤160/100 mmHg and ≥100/60 mmHg for all subjects. If a subject is currently prescribed beta-blocker therapy, BP at the screening visit must be ≤140/90 mmHg. In addition, heart rate must be ≥55 beats per minute if currently prescribed a beta-blocker and ≤60 beats per minute if not currently prescribed a beta-blocker.
- At least moderate risk for CAD.
Exclusion
- Participation in another clinical trial
- Ongoing ischemic (resting) limb pain, or lower extremity ulceration due to arterial insufficiency, or an ABI indicating \<0.6 indicating disease potentially requiring revascularization
- History of limb or digit amputation due to arterial insufficiency
- Revascularization of peripheral vessels within the preceding 6 months
- Uncontrolled hypertension as defined by systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg
- Contraindication or allergy to beta blocker therapy
- History of myocardial infarction , coronary revascularization, or a cerebrovascular event within the preceding 6 months
- Class III or IV angina
- Current or past history of New York Heart Association (NYHA) class III or IV heart failure
- Inability to walk on a treadmill for any reason
- Regular use of nitroglycerin or nitrates including oral, transdermal ointment or patch, or sublingual, translingual spray and/or combination agents containing nitrates
- Active liver, pulmonary, infectious or inflammatory process
- History of malignancy within preceding 5 years (excluding basal or squamous cell skin cancer)
- History of any other condition that, in the opinion of the investigators, renders it unsafe for the subject to be enrolled
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01499134
Start Date
August 1 2011
End Date
June 1 2014
Last Update
December 17 2014
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107