E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Type 2 Diabetes Mellitus and a history of TIA or stroke. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012613 |
E.1.2 | Term | Diabetes mellitus non-insulin-dependent |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023027 |
E.1.2 | Term | Ischaemic stroke NOS |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10044391 |
E.1.2 | Term | Transient ischemic attacks |
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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 |
To assess the long-term effects of Asasantin Retard® versus clopidogrel on established markers of inflammation as well as microalbuminuria in patients with type 2 diabetes mellitus and a history of TIA or stroke, using the DCA-2000 Analyzer, and time course of blood levels of CRP, MCP-1, and MMP-9 by ELISA. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
A. Documented diabetic nephropathy with microalbuminuria
(Defined by an albumin-creatinine-ratio of 3–30, measured in a sample of spot-urine).
B. History of TIA or stroke
C. Adults over 21 years old
D. Blood-pressure < 130/85 mmHg (with or without antihypertensive therapy)
E. Signed informed consent
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E.4 | Principal exclusion criteria |
A. Overt nephropathy (defined by an albumin-creatinine-ratio of >30, measured in a sample of spot-urine) or creatinine 250mmol/L.
B. Thrombolytic therapy or GP IIb/IIIa inhibitor within 30 days of enrollment
C. Platelet count < 100,000
D. History of bleeding disorder
E. Hct < 30, liver impairment defined as ALT/AST > 3 times ULN.
F. History of GI bleeding, hematochezia, or melena within 30 days.
G. Patients currently treated with any antiplatelet agent will be required to have a 14 day washout period prior to randomization.
H. Admission for acute coronary syndrome (unstable angina, MI), revascularization procedure with stent placement, or other major cardiovascular event within 30 days.
I. Active participation in other investigational drug or device trial within the last 30 days.
J. Allergy or intolerance to any of the study medications.
K. Insulin therapy
L. Pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
Microalbuminuria will be assessed in three timed, over-night urine samples at each time point. Mean value of the two samples with the highest values will be taken as the albumin excretion rate. Measurements will be performed by
immunoturbidometric method at Dep. of Clinical Chemistry at Aker University Hospital. In addition, the plasma levels of hsCRP, MCP-1, and MMP-9 will be determined at the Johns Hopkins Core Laboratory by ELISA.
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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 | No |
E.6.5 | Efficacy | Yes |
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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |