Comparison of 2 Beta Blocker Drugs on Peripheral Arterial Disease in Patients With High Blood Pressure

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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, hypertension, and at least moderate risk for coronary artery disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborator: Forest Laboratories
• Treatments: Metoprolol; Nebivolol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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