Long-term (3 years) ophthalmic safety and cardiac efficacy and safety of ivabradine administered orally at the therapeutic doses (2.5/5/7.5 mg twice daily [b.i.d.]) on top of anti-anginal background therapy, to patients with chronic stable angina pectoris
| ISRCTN | ISRCTN99185656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99185656 |
| Clinical Trials Information System (CTIS) | 2006-005475-17 |
| Protocol serial number | CL3-16257-067 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 18/01/2008
- Registration date
- 13/02/2008
- Last edited
- 21/04/2020
- 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
Prof Thomas Meinertz
Scientific
Scientific
Med. Univ. Klinic und Poliklinic - Abt. Für Kardiologie
Martinistr. 52
Hamburg
20246
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | International, parallel, double-blind placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Long-term (3 years) ophthalmic safety and cardiac efficacy and safety of ivabradine administered orally at the therapeutic doses (2.5/5/7.5 mg b.i.d.) on top of anti-anginal background therapy, to patients with chronic stable angina pectoris. An international, double-blind placebo controlled study. |
| Study objectives | The inhibition of the Hyperpolarization-activated (Ih) current present in the retina by ivabradine administered at the recommended doses leads to transient functional modifications of the retina. As of 23/07/2012, the following changes were made to this record: 1. The anticipated end date was extended from 01/05/2014 to 30/09/2015 2. The target number of participants was reduced from 300 to 100 As of 03/03/2011 the anticipated end date for this trial has been updated from 01/11/2012 to 01/05/2014. |
| Ethics approval(s) | Ethics approval received from the First Portuguese Ethics Committee on the 15/01/2008 |
| Health condition(s) or problem(s) studied | Chronic stable angina pectoris |
| Intervention | 1. 2.5 mg ivabradine orally (po) 2. 5 mg ivabradine po 3. 7.5 mg ivabradine po 4. Matching placebo Patients will receive treatment for 3 years. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ivabradine |
| Primary outcome measure(s) |
To document the absence of retinal toxicity in chronic stable angina patients assessed by ocular tests performed 2 months after a treatment exposure of 3 years. |
| Key secondary outcome measure(s) |
To document the long term cardiac efficacy and general ocular, cardiac and general safety. |
| Completion date | 30/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 97 |
| Key inclusion criteria | 1. Male or female patients (oral contraception if childbearing potential), aged greater than 18 years or having reached majority if the legal age of majority is above 18 years age and of any ethnic origin 2. Patients in sinus rhythm; resting heart rate greater than 60 beats per minute, with a history of chronic stable angina greater than 3 months before selection, no angina at rest and with a clinically stable angina greater than 3 months, at least 1 angina attack per month during the previous 3 months before selection 3. Patients who accept to undergo repeated visual tests and with a visual acuity greater than 0.5 |
| Key exclusion criteria | 1. Contra-indication to the administration of ivabradine 2. Patients with marked ocular conditions (significant altered vision and/or any evolutive underlying disease) known to have an impact on the ocular tests planned in the protocol |
| Date of first enrolment | 01/03/2008 |
| Date of final enrolment | 30/09/2015 |
Locations
Countries of recruitment
- Argentina
- Australia
- Belgium
- Finland
- Germany
- Hungary
- Ireland
- Portugal
- Singapore
- Sweden
Study participating centre
Med. Univ. Klinic und Poliklinic - Abt. Für Kardiologie
Hamburg
20246
Germany
20246
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Basic results | 21/04/2020 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
28/03/2018: Publication plan and IPD sharing statement amended.
25/01/2018: Publication plan and IPD sharing statement added.
11/12/2017: results summary.
