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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 September 2012 |
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Main ID: |
EUCTR2006-006246-34-HU |
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Date of registration:
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06/11/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Scientific title:
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Evaluation of the anti-anginal efficacy and safety of oral administration of ivabradine compared to placebo on top of a background therapy with a calcium antagonist (amlodipine or nifedipine) in patients with stable angina pectoris.
A 6-week randomised double-blind parallel-group international multicentre study. -
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Date of first enrolment:
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20/11/2008 |
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Target sample size:
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1240 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006246-34 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Bulgaria
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Estonia
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Hungary
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Latvia
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Lithuania
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Poland
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Male or female aged >= 18 years,
- History of chronic stable angina pectoris,
- Normal sinus rythm,
- Patients having been treated by amlodipine or nifedipine for at least 4 weeks before selection,
- Patients with documented coronary artery disease (CAD).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- Recent acute myocardial infarction, coronary bypass surgery or percutaneous coronary intervention,
- Resting angina, unstable angina, Prinzmetal angina or microvascular angina,
- Patient with a pacemaker or implanted cardioverter-defibrillator,
- Patient who cannot perform exercise tests,
- Congestive heart failure stage III or IV NYHA, uncontrolled heart failure,
- HR < 60 bpm measured on ECG at rest at selection.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Stable angina pectoris
MedDRA version: 9.1
Level: PT
Classification code 10002383
Term: Angina pectoris
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Intervention(s)
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Trade Name: PROCORALAN
Product Name: S16257
Product Code: S16257
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ivabradine
CAS Number: 155974-00-8
Current Sponsor code: S16257
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: PROCORALAN
Product Name: S16257
Product Code: S16257
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: S16257-2
CAS Number: 155974-00-8
Current Sponsor code: S16257
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7,5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: - To demonstrate that over a 6-week treatment period ivabradine is more efficacious than placebo when given in combination with calcium antagonists (amlodipine or nifedipine) in patients with stable chronic effort angina pectoris.
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Secondary Objective: - To demonstrate the superiority of ivabradine versus placebo when given in combination with calcium antagonists (amlodipine or nifedipine) on the change of ETT criteria at the trough and at the peak of ivabradine activity over a 6-week treatment period and on the change in the mean number of angina attacks per week,
- To compare the change in the mean consumption of short acting nitrate per week between ivabradine and placebo when given in combination with calcium antagonists (amlodipine or nifedipine) over a 6-week treatment period,
- To assess the change of HR and RPP over a 6-week treatment period of ivabradine versus placebo when given in combination with calcium antagonists (amlodipine or nifedipine) at the trough and at the peak of ivabradine activity,
- To compare the safety and tolerability profile of ivabradine to placebo when given in combination with calcium antagonists (amlodipine or nifedipine) over a 6-week treatment period.
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Primary end point(s): The response to treatment, evaluated over a 6-week treatment period and defined as a decrease of at least 3 angina attacks per week and/or an increase in the time to 1 mm ST segment depression of at least 60 s during a treadmill exercise tolerance test (ETT).
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Secondary ID(s)
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CL3-16257-068
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2006-006246-34-LV
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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