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

NCT01499134 | Completed Phase 3 Results DMC

• 1 other identifier: 11C.18
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Peripheral Artery Disease; Hypertension

Outcome Measures

Primary Outcomes (1)

• Peak Walking Time (PWT)

  Change in peak walking time (PWT) is measured in seconds. The PWT is defined as when walking on a treadmill cannot continue due to maximal leg pain, resulting in the discontinuation of the treadmill test.

  Baseline PWT is measured at the time of enrollment and again at the final study visit at 26 weeks.

Secondary Outcomes (7)

• Ankle-brachial Index (ABI)

  Baseline ABI is measured at the time of enrollment and again at the final study visit at 26 weeks

• Claudication Onset Time (COT)

  Baseline COT is measured at the time of enrollment and again at the final study visit at 26 weeks.

• Walking Impairment Questionnaire (WIQ) - Change Calf Pain

  Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.

• Walking Impairment Questionnaire (WIQ) - Change in Buttock Pain

  Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.

• Walking Impairment Questionnaire (WIQ) - Change in WIQ Distance Score

  Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.

Study Arms (2)

nebivolol

EXPERIMENTAL

nebivolol 1 to 4 capsules daily

Drug: nebivolol

metoprolol succinate

ACTIVE COMPARATOR

metoprolol 1 to 4 capsules daily

Drug: Metoprolol succinate

Interventions

nebivolol DRUG

Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing).

Also known as: Bystolic

nebivolol

Metoprolol succinate DRUG

Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing).

Also known as: Toprol XL

metoprolol succinate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Hypertension

Interventions

Nebivolol; Metoprolol

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenoxypropanolamines; Propanolamines; Propanols

Results Point of Contact

• Title: Danielle Duffy MD
• Organization: Thomas Jefferson University

Danielle.Duffy@jefferson.edu

215 955 5050

Study Officials

• Danielle Duffy, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: December 26, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 17, 2014
• Results First Posted: December 3, 2014

Record last verified: 2014-12

Locations

US (1)