E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051592 |
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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 MAIN OBJECTIVE OF THIS STUDY IS TO ASSESS IF A TWO-MONTH REGIMEN OF IRBESARTAN IN PATIENTS HOSPITALIZED FOR ACUTE CORONARY SYNDROME WITHOUT ST SEGMENT ELEVATION CAN REDUCE INFLAMMATION MARKERS ie hsCRP ,IN COMPARISON TO ENALAPRIL |
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E.2.2 | Secondary objectives of the trial |
TO COMPARE BOTH REGIMENS ON SEVERAL OTHER BIOLOGICAL PARAMETERS WHICH HAVE DEMONSTRATED THEIR RELEVANCE AND THEIR PREDICTIVE CLINICAL VALUE ie BNP, microalbuminuria,troponin I in this patient population. TO COMPARE ON THE ABOVE PARAMETERS THE EARLY INITIATION OF TREATMENT VERSUS THE INITIATION OF TREATMENT AT HOSPITAL DISCHARGE. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients male or female 1 Age or to 18 years old 2 Patients hospitalized with ischemic symptoms last episode within the last 48 hours before randomization and at least one of the following characteristics of acute coronary syndrome without persistent ST segment elevation - ECG ST or T changes ST depression or transient elevation of at least 1mm or T wave changes in at least 2 leads - Positive troponin according to local threshold 3 Signed written informed consent obtained |
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E.4 | Principal exclusion criteria |
RELATED TO THE PATIENT. 1 Women of child bearing potential WCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study WOCBP using a prohibited contraceptive method not applicable 2 Women pregnant or breast feeding 3 Women with a positive pregnancy test on enrolment or prior to study drug administration 4 Subjects with inability to follow protocol procedures according to the investigation. 5 Patients with dementia. 6 Patients unable to come back at all follow-up visits. RELATED TO THE DISEASE / CONCOMITAMT DISEASES. 7 Persistent ST segment elevation at ECG. 8 Systolic blood pressure 100mmHg. 9 Bilateral stenosis of renal artery. 10 Creatinine clearance or to 30 ml/mn based on admission serum creatinine value and the Cockcroft formula 11 Congestive hearth failure with symptoms consistent with New York Hearth Association NYHA class III or IV. 12 Aortic or mitral valve stenosis 13 Hypertrophic cardiomyopathy 14 Connective tissue disease with vascular involvement 15 Angioplasty or surgery or trauma within the last 3 months. 16 Coronarography/angioplasty planned to be performed or performed before baseline sampling. 17 Febrile disease or to 38 C , known concomitant viral or bacterial infection, chronic auto immune disease, chronic inflammatory disease, known cancer in evolution. 18 Hyperkalemia serum potassium 5.5 mmol/l. 19 Life expentancy less than one year. RELATED TO STUDY DRUG/CONCOMITANT THERAPY. 20 Sensitivity or intolerance to ARBs olmesartan, candesartan, irbesartan, eprosartan, losartan, telmisartan, valsartan and/or any other ARB currently or previously in development . 21 Sensitivity or intolerance to ACE-I benazepril, captopril, enalapril, lisinopril, trendolapril, ramipril, quinapril, and/or any other ACE-I currently or previously in development. 22 Chronic steroid or non steroidal anti inflammatory drugs NSAIDs use. Aspirin is permitted. 23 Treatment with allopurinol or procainamide 24 Concomintant use of potassium sparing diuretics e.g. spironolactone, triamterene or amiloride , potassium preparations, or salt substitutes containing potassium 25 Treatment with lithium. 26 Immunosupressive medication. 27 Administration of any other investigational drug in the last 30 days before enrollment and during the course of the study. OTHER EXCLUSION CRITERIA. 28 Prisoners or subjects who are compulsorily detained involuntarily incarcerated for treatment or either a psychiatric or physical e.g., infectious disease illness must not be enrolled into this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy outcome comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups. |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |