|
ISRCTN
|
ISRCTN06278310
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Nebivolol or Metoprolol in Arterial Occlusive Disease
|
|
Scientific title
|
Nebivolol or Metoprolol in Arterial Occlusive Disease: A double-blind, randomised controlled trial
|
|
Acronym
|
NORMA
|
|
Serial number at source
|
BCBe/05/Neb-Pao/088
|
|
Study hypothesis
|
To assess the effects of nebivolol compared to metoprolol on endothelial function by means of flow mediated dilation
|
|
Lay summary
|
|
|
Ethics approval
|
The local research ethics board approved on the 23rd of February 2006 (ref: 837.025.06[5123])
|
|
Study design
|
Double blind randomised active controlled parallel group trial
|
|
Countries of recruitment
|
Germany
|
|
Disease/condition/study domain
|
Peripheral arterial occlusive disease
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/02/2006
|
|
Anticipated end date
|
01/04/2010
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use contact details below to request a patient information sheet
|
|
Target number of participants
|
128
|
|
Interventions
|
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 measure(s)
|
Flow mediated dilation
All outcomes were measured at screening, baseline and the end of the intervention period (52 weeks).
|
|
Secondary outcome measure(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).
|
|
Sources of funding
|
Berlin-Chemie (Germany) (part of Menarini Group [Italy])
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
Gerhard
Weisser
|
|
Address
|
II. Med. Klinik; Angiologie
Langenbeckstr. 1
Gebäude 701; 2.OG
|
|
City/town
|
Mainz
|
|
Zip/Postcode
|
55131
|
|
Country
|
Germany
|
|
Sponsor
|
Berlin-Chemie (Germany) (part of Menarini Group [Italy])
|
|
Address
|
Glienicker Weg 125
|
|
City/town
|
Berlin
|
|
Zip/Postcode
|
12489
|
|
Country
|
Germany
|
|
Date applied
|
08/06/2010
|
|
Last edited
|
24/06/2010
|
|
Date ISRCTN assigned
|
24/06/2010
|
