Nebivolol or Metoprolol in Arterial Occlusive Disease

• Register: ISRCTN
• Last refreshed on: 27 May 2019
• Main ID: ISRCTN06278310
• Date of registration: 24/06/2010
• Prospective Registration: No
• Primary sponsor: Berlin-Chemie (Germany) (part of Menarini Group [Italy])
• Public title: Nebivolol or Metoprolol in Arterial Occlusive Disease
• Scientific title: Nebivolol or Metoprolol in Arterial Occlusive Disease: A double-blind, randomised controlled trial
• Date of first enrolment: 01/02/2006
• Target sample size: 128
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN06278310
• Study type: Interventional
• Study design: Double blind randomised active controlled parallel group trial (Treatment)
• Phase: Phase III

Countries of recruitment

Germany

Contacts

• Name: Gerhard Weisser

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Peripheral arterial occlusive disease
Circulatory System
Other peripheral vascular diseases

Intervention(s)

Patients randomised to receive either:
1. Nebivolol (Nebilet 5mg po once daily)
2. Metoprolol (Metoprolol succ. 95mg po once daily)
Total duration 52 weeks for all arms.

Primary Outcome(s)

Flow mediated dilation
All outcomes were measured at screening, baseline and the end of the intervention period (52 weeks).

Secondary Outcome(s)

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

Secondary ID(s)

BCBe/05/Neb-Pao/088

2005-003583-31

Source(s) of Monetary Support

Berlin-Chemie (Germany) (part of Menarini Group [Italy])

Ethics review

Status:
Approval date:
Contact:

The local research ethics board approved on the 23rd of February 2006 (ref: 837.025.06[5123])

Results

• Results available: Yes
• Date Completed: 01/04/2010