E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
NIDDM (non insulin dependent diabetes mellitus) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Classification code | 10029402 |
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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 determine the difference in the time to event of microalbuminuria in patients receiving 40 mg olmesartan medoxomil compared to placebo using morning spot urine collections, assessed from baseline until occurrence of microalbuminuria. |
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E.2.2 | Secondary objectives of the trial |
To test the hypothesis that treatment with olmesartan medoxomil has a positive effect on cardiovascular and renal morbidity and mortality, as evaluated by: Cardiovascular mortality -sudden death and fatal MI -fatal stroke -combined endpoint Cardiovascular morbidity -coronary artery disease due to angina pectoris -myocardial insufficiency due to heart failure -transitory ischaemic attack, non-fatal myocardial infarction, non-fatal stroke -peripheral vascular disease -combined endpoint Renal disease -end-stage renal disease -worsening of renal function -combined endpoint Retinopathy -occurrence/progression of retinopathy -microvascular morbidity Analyse Subgroups -age and date of diagnosis and prognostic factors from beginning to end Safety and Tolerability -safety and tolerability of treatment
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-male or female patients with type II diabetes mellitus defined by the American Diabetes Association (ADA) criteria (fasting blood glucose ³ 126 mg/dL (7 mmol/L)) or receiving treatment for diabetes who have at least one of the following cardiovascular risk factors: - Lipid disorder defined as: total cholesterol > 200 mg/dL (5.2 mmol/L) or receiving treatment for hyperlipidaemia. - HDL < 40 mg/dL (1.1 mmol/L). - Triglycerides > 150 mg/dL (1.7 mmol/L) and < 400 mg/dL (4.5 mmol/L). - blood pressure: sBP ³ 130 mmHg and/or dBP ³ 80 mmHg. - obesity: BMI ³ 28 m2/kg. - waist circumference: > 102 cm for men, >88 cm for women. - smoking: more than 5 cigarettes a day -normoalbuminuria at Screening less than or equal to 35 mg albumin/g urine creatinine for women and less than or equal to 25 mg albumin/g urine creatinine for men (confirmed by two independent measurements within two weeks). |
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E.4 | Principal exclusion criteria |
patients with severe hyperlipidaemia (high lipid values not controlled by usual treatment).- patients with documented renal and/or renal-vascular disease. - patients with myocardial infarction (MI), stroke or myocardial revascularization within the last 6 months. - patients with a history of drug abuse. - patients with alcohol addiction within the last two years. - patients with known allergic reaction, lack of response or contraindication to Ang II-antagonists. - patients receiving angiotensin receptor blocker (ARB) or angiotensin converting enzyme (ACE) inhibitor (within last 6 months). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to the first occurrence of microalbuminuria defined as albumin excretion in morning urine (collected as spot urine) of > 35 mg albumin/g urine creatinine for women and > 25 mg albumin/g urine creatinine for men. |
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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 | Yes |
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 | No |
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 | 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 | Information not present in EudraCT |
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.8.5 | 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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When 325 events of microalbuminuria are reported, the clinical part of the study will be completed. See protocol. |
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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 | 7 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial months | 0 |