Angina PectorisPhase 3ASSOCIATENCT00202566
Efficacy and Safety of Ivabradine on Top of Atenolol in Stable Angina Pectoris
A Phase 3 study testing Ivabradine in people with Angina Pectoris, run by Institut de Recherches Internationales Servier at 1 site in Canada.
Trial summary
To test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Ivabradine
- How many people
- 750 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to Oct 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stable angina pectoris
- Documented coronary artery disease
- Previous treatment with atenolol or other beta-blocker agent
- Exercise tolerance test positivity and stability
Who cannot join
- Heart rate < 60 bpm
- Congestive heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Anti-anginal Efficacy and Safety of Oral Administration of Ivabradine Compared to Placebo on Top of Background Therapy With Atenolol in Patients With Stable Angina Pectoris. A Four-month Randomised Double-blind, Parallel Group International Multicentre Study.
To test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris
- Conditions
- Angina Pectoris
- Being tested
- Ivabradine
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement between baseline and end of treatment of the treadmill exercise tolerance test
Secondary outcomes (2)
Rate pressure product
Clinical evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2005
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Claude Tardif, Pr, Study chair, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202566
- Sponsor's protocol ID
- CL3-16257-057
- Acronym
- ASSOCIATE
- Status last verified
- Mar 2018
- First submitted
- 12 Sep 2005
- Last updated
- 15 Mar 2018
- Results posted
- No
- Individual data sharing
- Yes: Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Publications
Tardif JC, Ponikowski P, Kahan T; ASSOCIATE Study Investigators. Efficacy of the I(f) current inhibitor ivabradine in patients with chronic stable angina receiving beta-blocker therapy: a 4-month, randomized, placebo-controlled trial. Eur Heart J. 2009 Mar;30(5):540-8. doi: 10.1093/eurheartj/ehn571. Epub 2009 Jan 9.
PubMed 19136486
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Anti-anginal Efficacy and Safety of Oral Administration of Ivabradine Compared to Placebo on Top of Background Therapy With Atenolol in Patients With Stable Angina Pectoris. A Four-month Randomised Double-blind, Parallel Group International Multicentre Study.
- ClinicalTrials.gov ID
- NCT00202566
- Acronym / sponsor ID
- ASSOCIATE / CL3-16257-057
- Conditions
- Angina Pectoris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Oct 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic stable angina pectoris
- Documented coronary artery disease
- Previous treatment with atenolol or other beta-blocker agent
- Exercise tolerance test positivity and stability
Key exclusion criteria (2 listed)
- Heart rate < 60 bpm
- Congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivabradine | Drug | – |
Primary outcome
Improvement between baseline and end of treatment of the treadmill exercise tolerance test
2 secondary outcomes
Rate pressure product
Clinical evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Results publication: PubMed 19136486Tardif JC, Ponikowski P, Kahan T; ASSOCIATE Study Investigators. Efficacy of the I(f) current inhibitor ivabradine in patients with chronic stable angina receiving beta-blocker therapy: a 4-month, randomized, placebo-controlled trial. Eur Heart J. 2009 Mar;30(5):540-8. doi: 10.1093/eurheartj/ehn571. Epub 2009 Jan 9.
- Individual participant dataSharing planned: Yes. Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Claude Tardif, Pr study chair
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivabradine in people with Angina Pectoris, run by Institut de Recherches Internationales Servier at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement between baseline and end of treatment of the treadmill exercise tolerance test. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00202566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.