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

Completed · Phase 3

Conditions studied: Peripheral Artery Disease, Hypertension

In brief

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.

Key facts

Study ID

NCT01499134

Run by

Thomas Jefferson University

People needed

17

Starts

2011-08-01

Expected to finish

2014-06-01

Last updated by the study team

2014-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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