Additional identifiers
EudraCT/CTIS number
2005-003583-31
IRAS number
ClinicalTrials.gov number
Protocol/serial number
BCBe/05/Neb-Pao/088
Study information
Scientific title
Nebivolol or Metoprolol in Arterial Occlusive Disease: A double-blind, randomised controlled trial
Acronym
NORMA
Study hypothesis
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])
Study design
Double blind randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Pharmaceutical study type(s)
Phase
Phase III
Drug/device/biological/vaccine name(s)
Nebivolol, metoprolol
Primary outcome measure
Flow mediated dilation
All outcomes were measured at screening, baseline and the end of the intervention period (52 weeks).
Secondary outcome measures
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).
Overall study start date
01/02/2006
Overall study end date
01/04/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
128
Participant 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
Recruitment start date
01/02/2006
Recruitment end date
01/04/2010
Locations
Countries of recruitment
Germany
Study participating centre
II. Med. Klinik; Angiologie
Mainz
55131
Germany
Sponsor information
Organisation
Berlin-Chemie (Germany) (part of Menarini Group [Italy])
Sponsor details
Glienicker Weg 125
Berlin
12489
Germany
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Berlin-Chemie (Germany) (part of Menarini Group [Italy])
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 16/05/2019 | No | No |