ADDITIONS: Practical daily efficacy and safety or Procoralan® in combination with betablockers

ISRCTN	ISRCTN53233058
DOI	https://doi.org/10.1186/ISRCTN53233058
Protocol serial number	IC4-16257-105-DEU
Sponsor	Servier Deutschland GmbH (Germany)
Funder	Servier Deutschland GmbH (Germany)

Submission date: 15/03/2010
Registration date: 22/04/2010
Last edited: 20/06/2017

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 and not expected to be available in the future

Contact information

Dr Martin Kuehn
Scientific

Elsenheimerstr: 53
Munich
80687
Germany

Phone	+49 (0)89 5709501
Email	martin.kuehn@de.netgrs.com

Study information

Primary study design	Observational
Study design	Observational prospective multicentre study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	ADDITIONS: Practical daily efficacy and safety or Procoralan® in combination with betablockers: Observational prospective multicentre study
Study acronym	ADDITIONS
Study objectives	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(s)	Ethics Committee of Martin-Luther University Halle-Wittenberg, 23/02/2010
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	None
Completion date	30/05/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	6000
Key inclusion criteria	Adult patients, either sex, with stable angina pectoris and on betablocker therapy prior to inclusion
Key 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
Date of first enrolment	08/03/2010
Date of final enrolment	30/09/2010

Locations

Countries of recruitment

Germany

Study participating centre

Elsenheimerstr: 53

Munich
80687
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2012		Yes	No
Results article	results	01/02/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/06/2017: Publication reference added.
24/03/2016: Publication reference added.