Condition category
Circulatory System
Date applied
15/03/2010
Date assigned
22/04/2010
Last edited
24/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Kuehn

ORCID ID

Contact details

Elsenheimerstr: 53
Munich
80687
Germany
+49 (0)89 5709501
martin.kuehn@de.netgrs.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IC4-16257-105-DEU

Study information

Scientific title

ADDITIONS: Practical daily efficacy and safety or Procoralan® in combination with betablockers: Observational prospective multicentre study

Acronym

ADDITIONS

Study hypothesis

Effects of therapy with Procoralan® in combination with betablockers on angina symptoms in patients with stable angina pectoris under daily routine in an observational prospective multicentre trial by general practioners, internists and cardiologists.

Ethics approval

Ethics Committee of Martin-Luther University Halle-Wittenberg, 23/02/2010

Study design

Observational prospective multicentre study

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 the contact details below to request a patient information sheet

Condition

Stable angina pectoris

Intervention

Observational study to get information about therapy with Procoralan® in combination with betablockers under daily routine practice by general practitioners, internists and cardiologists.

The diagnosis of angina will be confirmed by trialists at baseline. After the baseline visit, there is a visit after 4 weeks and the final visit after 4 months.
For the follow up there are additional visits after 8 and 12 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Change in angina symptoms (number of angina attacks, consumption of short acting nitrates per week)
2. Effects of the therapy on quality of life via patients questionaire (EQ-5D)
3. Effects of therapy on resting heart rate
4. Information about how Procoralan® SmPC and patients information are followed via standardised documentation of the dosage of Procoralan®, of comedications, and concomitant diseases
5. Analysis of general tolerability of Procoralan® under routine conditions via standardised adverse reactions documentation and standardised documentation of therapy discontinuation
6. Analysis of unknown adverse drug reactions via standardised documentation

Secondary outcome measures

None

Overall trial start date

08/03/2010

Overall trial end date

30/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients, either sex, with stable angina pectoris and on betablocker therapy prior to inclusion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

6000

Participant exclusion criteria

1. Does not meet inclusion criteria
2. In addition, doctors involved in the trial should follow the Summary of Product Characteristics (SmPC) for Procoralan®, which includes the following contraindications:
2.1. Hypersensitivity to the active substance or to any of the excipients
2.2. Resting heart rate below 60 beats per minute prior to treatment
2.3. Cardiogenic shock
2.4. Acute myocardial infarction
2.5. Severe hypotension (< 90/50 mmHg)
2.6. Severe hepatic insufficiency
2.7. Sick sinus syndrome
2.8. Sino-atrial block
2.9. Heart failure patients with New York Heart Association (NYHA) functional classification III-IV
2.10. Pacemaker dependent
2.11. Unstable angina
2.12. Atrioventricular (AV) block of 3rd degree
2.13. Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone
2.14. Pregnancy, lactation

Recruitment start date

08/03/2010

Recruitment end date

30/05/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Elsenheimerstr: 53
Munich
80687
Germany

Sponsor information

Organisation

Servier Deutschland GmbH (Germany)

Sponsor details

Elsenheimerstr. 53
Munich
80687
Germany
+49 (0)89 5709601
martin.kuehn@de.netgrs.com

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Servier Deutschland GmbH (Germany)

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25687888

Publication citations

Additional files

Editorial Notes

24/03/2016: Publication reference added.