Comparison of 2 Beta Blocker Drugs on Peripheral Arterial Disease in Patients With High Blood Pre… (NCT01499134) | Clinical Trial Compass
CompletedPhase 3
Comparison of 2 Beta Blocker Drugs on Peripheral Arterial Disease in Patients With High Blood Pressure
United States17 participantsStarted 2011-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Peak Walking Time (PWT)
Timeframe: Baseline PWT is measured at the time of enrollment and again at the final study visit at 26 weeks.