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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN53233058

Enrollment

6000

Registered

2010-04-22

Start date

2010-03-08

Completion date

Unknown

Last updated

2017-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable angina pectoris Circulatory System Angina Pectoris

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 12, 2026