Nebivolol or Metoprolol in Arterial Occlusive Disease
| ISRCTN | ISRCTN06278310 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06278310 |
| EudraCT/CTIS number | 2005-003583-31 |
| Secondary identifying numbers | BCBe/05/Neb-Pao/088 |
- Submission date
- 08/06/2010
- Registration date
- 24/06/2010
- Last edited
- 16/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Gerhard Weisser
Scientific
Scientific
II. Med. Klinik; Angiologie
Langenbeckstr. 1
Gebäude 701; 2.OG
Mainz
55131
Germany
Study information
| 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 |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 |
| 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 |
| Completion date | 01/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
II. Med. Klinik; Angiologie
Mainz
55131
Germany
55131
Germany
Sponsor information
Berlin-Chemie (Germany) (part of Menarini Group [Italy])
Industry
Industry
Glienicker Weg 125
Berlin
12489
Germany
"ROR" |
https://ror.org/05gja4j15 |
|---|
Funders
Funder type
Industry
Berlin-Chemie (Germany) (part of Menarini Group [Italy])
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 16/05/2019 | No | No |
Editorial Notes
16/05/2019: Added clinicaltrialsregister.eu link to basic results (scientific).
