Phase 3 N=17 Randomized Quadruple-blind Treatment

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

Peripheral Artery Disease · Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01499134 ↗

Enrolled (actual)

Serious AEs

11.8%

Results posted

Dec 2014

Primary outcome: Primary: Peak Walking Time (PWT) — 110.4; -19.4 seconds — p=0.039

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: nebivolol (Drug); Metoprolol succinate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Thomas Jefferson University
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Peak Walking Time (PWT)	110.4; -19.4	0.039 sig
SECONDARY Ankle-brachial Index (ABI)	0.03; 0.06	0.585
SECONDARY Claudication Onset Time (COT)	155.7; 148.7	1.000
SECONDARY Walking Impairment Questionnaire (WIQ) - Change Calf Pain	25; 10.7	0.363
SECONDARY Walking Impairment Questionnaire (WIQ) - Change in Buttock Pain	-8.3; 14.3	0.017 sig
SECONDARY Walking Impairment Questionnaire (WIQ) - Change in WIQ Distance Score	13.52; 28.28	0.476
SECONDARY Walking Impairment Questionnaire (WIQ) - Change in WIQ Speed Score	21.88; -6.83	0.170
SECONDARY Walking Impairment Questionnaire (WIQ) - Change in WIQ Stairs Score	21.67; 24.31	0.595

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01499134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.