ADDITIONS: Practical daily efficacy and safety or Procoralan® in combination with betablockers
ISRCTN | ISRCTN53233058 |
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DOI | https://doi.org/10.1186/ISRCTN53233058 |
Secondary identifying numbers | IC4-16257-105-DEU |
- 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
Scientific
Elsenheimerstr: 53
Munich
80687
Germany
Phone | +49 (0)89 5709501 |
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martin.kuehn@de.netgrs.com |
Study information
Study design | Observational prospective multicentre study |
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Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 08/03/2010 |
Completion date | 30/05/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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
80687
Germany
Sponsor information
Servier Deutschland GmbH (Germany)
Industry
Industry
Elsenheimerstr. 53
Munich
80687
Germany
Phone | +49 (0)89 5709601 |
---|---|
martin.kuehn@de.netgrs.com | |
Website | http://www.servier.com/ |
https://ror.org/05wk4ae67 |
Funders
Funder type
Industry
Servier Deutschland GmbH (Germany)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Data sharing statement to be made available at a later date |
Publication and dissemination plan | |
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 |
Editorial Notes
20/06/2017: Publication reference added.
24/03/2016: Publication reference added.