Condition category
Circulatory System
Date applied
08/06/2010
Date assigned
24/06/2010
Last edited
24/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Gerhard Weisser

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2005-003583-31

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

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

Trial setting

Hospitals

Trial 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

Phase

Phase III

Drug names

Nebivolol, metoprolol

Primary outcome measures

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 trial start date

01/02/2006

Overall trial end date

01/04/2010

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes