ebivolol or Metoprolol in Arterial Occlusive Disease

Phase 3

Completed

• Conditions: Peripheral arterial occlusive disease; Circulatory System; Other peripheral vascular diseases

• Registration Number: ISRCTN06278310
• Lead Sponsor: Berlin-Chemie (Germany) (part of Menarini Group [Italy])

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-04-01
• Study Start: 2010-06-24
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1. Male patients 30 years to 80 years or female postmenopausal patients up to 80 years
2. Arterial occlusive disease Fontaine´s stage II A or B
3. Stage I hypertension according to Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC) with or without hypertensive treatment

Exclusion Criteria

1. Arterial occlusive disease with rest pain or leg ulcer
2. Any concomitant disease limiting the exercise capacity of the patient
3. Poorly controlled diabetes HbA1c > 10%
4. Acute myocardial infarction during the last 6 month
5. Treatment with COX-2 inhibitors
6. Previous treatment with nebivolol or carvedilol
7. Concomitant treatment with drugs that may influence endothelial function
8. Contraindication to the study drug
9. Participation in an other clinical trail the last 6 month
10. Acute pathologic haemorrhage
11. Known hyperthyoidism
12. Psychiatric diseases
13. Known hypersensivity to nebivolol or metoprolol
14. Prior or active malignancy in the previous 5 years
15. History of drug or alcohol abuse
16. Unwilling or unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Flow mediated dilation<br> All outcomes were measured at screening, baseline and the end of the intervention period (52 weeks).<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Walking distance<br> 2. Ankle brachial index<br> 3. Systolic and diastolic blood pressure<br> 4. Quality of Life<br> 5. Laboratory parameters<br> 6. Cludation Scale (CLAU-S) questionnaire<br> All outcomes were measured at screening, baseline and the end of the intervention period (52 weeks).<br>