Nebivolol or Metoprolol in Arterial Occlusive Disease

ISRCTN	ISRCTN06278310
DOI	https://doi.org/10.1186/ISRCTN06278310
Clinical Trials Information System (CTIS)	2005-003583-31
Protocol serial number	BCBe/05/Neb-Pao/088
Sponsor	Berlin-Chemie (Germany) (part of Menarini Group [Italy])
Funder	Berlin-Chemie (Germany) (part of Menarini Group [Italy])

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Gerhard Weisser
Scientific

II. Med. Klinik; Angiologie
Langenbeckstr. 1
Gebäude 701; 2.OG
Mainz
55131
Germany

Primary study design	Interventional
Study design	Double blind randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Nebivolol or Metoprolol in Arterial Occlusive Disease: A double-blind, randomised controlled trial
Study acronym	NORMA
Study objectives	To assess the effects of nebivolol compared to metoprolol on endothelial function by means of flow mediated dilation
Ethics approval(s)	The local research ethics board approved on the 23rd of February 2006 (ref: 837.025.06[5123])
Health condition(s) or problem(s) studied	Peripheral arterial occlusive disease
Intervention	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.
Intervention type	Drug
Phase	Phase III
Drug / device / biological / vaccine name(s)	Nebivolol, metoprolol
Primary outcome measure(s)	Flow mediated dilation All outcomes were measured at screening, baseline and the end of the intervention period (52 weeks).
Key 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).
Completion date	01/04/2010

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	128
Key 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
Key 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
Date of first enrolment	01/02/2006
Date of final enrolment	01/04/2010

II. Med. Klinik; Angiologie

Mainz
55131
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results			16/05/2019	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

16/05/2019: Added clinicaltrialsregister.eu link to basic results (scientific).