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 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
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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 Protein Pattern and Serum Inflammatory Markers -effects on serum inflammatory markers in a sub-group. -effects on urinary protein pattern in a sub-group.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female Caucasian patients with Type II diabetes mellitus aged between 18 and 75 years 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 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) - Hypertension: sBP > or = 130 mmHg and/or dBP > or = 80 mmHg - Obesity: BMI > or = 28 kg/sq.m - Waist circumference: > 102 cm for men, >88 cm for women - Smoking: more than 5 cigarettes a day - Patients with fasting blood glucose > or = 126 mg/dL (7 mmol/L) (only for patients not receiving treatment for diabetes) - Patients with HbA1c > or = 6.5 % (only for patients not receiving treatment for diabetes) - Patients with normoalbuminuria at screening: < or = 35 mg albumin/g urine creatinine for women and < or = 25 mg albumin /g urine creatinine for men
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E.4 | Principal exclusion criteria |
- Patients with documented renal and/or renal vascular disease - Patients with myocardial infarction, stroke, transient ischaemic attack or myocardial revascularisation or reperfusion within the last 6 months - Patients with ASAT and ALAT greater than twice the upper limit of the laboratory reference range. Patients with GGT greater than twice the upper limit will only be excluded if ASAT or ALAT are greater than 1.5 times the upper limits - Patients with known allergic reaction, lack of response or contraindication to ARBs - Patients with severe hypertension (sBP > 200 mmHg and/or dBP > 110 mmHg) - Patients with severe heart failure: NYHA Stage 3-4 - Patients with a history of drug abuse or within the last two years, alcohol addiction - Patients receiving ARBs or ACE inhibitors within the last 6 months - Patients with severe hyperlipidaemia - Patients requiring psychoactive drugs (except anti-anxiety drugs, anti-depressants and medications used for the treatment of sleeping disorders). Selective serotonin reuptake inhibitors (SSRIs) are not allowed |
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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 | 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.8.5 | 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 | 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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When 326 events of microalbuminuria are reported, the clinical part of the study will be completed. |
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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 | 6 |
E.8.9.1 | In the Member State concerned months | 8 |
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 |