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
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details 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 measure
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 (if study stopped)
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
30/09/2010
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
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
IPD sharing statement
The current data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22231643
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25687888