E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of FOCUS is to evaluate clinical safety outcomes (cardiovascular and noncardiovascular) in subjects receiving long-term (> 36 months) AGI-1067 treatment. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female subjects who have completed the ARISE trial are eligible to participate in FOCUS. Main inclusion criteria ARISE trial: - Subjects with a recent diagnosis of coronary artery disease as evidenced by an admission with a diagnosis of Acute MI or unstable angina not less than 14 days and not more than one year prior to randomization - Male or female subjects in one of the two following groups: a) Subjects with diabetes mellitus (NIDDM or IDDM) 18 years of age or older b) Subjects (without diabetes mellitus) 55 years of age or older with one of the following additional risk factors:(1) Age 60 or older (2) Low HDL-C (3) Previous Myocardial Infarction, or diagnosis of Atherosclerosis in a non-coronary vessel (4) Prior history of CHF (Congestive Heart Failure) or ejection fraction < 40% - Females must be non-lactating and not of child bearing potential (post-menopausal or surgically sterilized) or must use a reliable method of birth control considered suitable by the Investigator. |
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E.4 | Principal exclusion criteria |
Male or female subjects who have completed the ARISE trial are eligible to participate in FOCUS. Main exclusion criteria ARISE trial: - Subjects who are hemodynamically or clinically unstable - Subjects who have had a PCI in the last 30 days - Subjects who have had coronary artery bypass (CAB) or coronary artery bypass graft (CABG) surgery in the last 3 months - Subjects on a waiting list for revascularization or revascularization already planned - Current symptoms consistent with moderate or severe CHF despite medical therapy - In the opinion of the Principal Investigator (or designee), clinically significant valvular heart disease or Hypertrophic Obstructive Cardiomyopathy - Uncontrolled hypertension - Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the Investigator - Subjects taking and requiring continued therapy with antiarrhythmic medications - A history of intolerance to probucol |
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E.5 End points |
E.5.1 | Primary end point(s) |
10 major adverse cardiovascular events:
1. All death to determine cardiovascular death 2. Non-fatal myocardial infarction 3. Resuscitated cardiac arrest 4. Use of coronary revascularization 5. Hospitalization for angina pectoris 6. Hospitalization for CHF 7. Fatal, non-fatal stroke and Transient ischemic attack (TIA) 8. New onset Diabetes Mellitus (NODM) 9. Any admission for a procedure for the treatment of PVD 10. Incidence of End Stage Renal Disease (ESRD)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 22 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |