Condition category
Circulatory System
Date applied
18/01/2008
Date assigned
13/02/2008
Last edited
08/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Meinertz

ORCID ID

Contact details

Med. Univ. Klinic und Poliklinic - Abt. Für Kardiologie
Martinistr. 52
Hamburg
20246
Germany

Additional identifiers

EudraCT number

2006-005475-17

ClinicalTrials.gov number

Protocol/serial number

CL3-16257-067

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the First Portuguese Ethics Committee on the 15/01/2008

Study design

International, parallel, double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Ivabradine

Primary outcome measures

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.

Secondary outcome measures

To document the long term cardiac efficacy and general ocular, cardiac and general safety.

Overall trial start date

01/03/2008

Overall trial end date

30/09/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/03/2008

Recruitment end date

30/09/2015

Locations

Countries of recruitment

Argentina, Australia, Belgium, Finland, Hungary, Ireland, Portugal, Singapore, Sweden

Trial participating centre

Med. Univ. Klinic und Poliklinic - Abt. Für Kardiologie
Hamburg
20246
Germany

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes