E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We will investigate the effect of Olmesartan Medoxomil 40 mg on the reendothelialization capacity of Endothelial Progenitor Cells in patients with chronic kidney disease. In this clinical setting Olmesartan Medoxomil is expected to have tissue protective effeects. |
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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 |
To study the effects of Olmesartan Medoxomil 40 mg on the re-endothelialization capacity of Endothelial Progenitor Cells in patients with chronic kidney disease |
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E.2.2 | Secondary objectives of the trial |
to assess the effects of Olmesartan Medoxomil 40 mg on endothelial function, number and function of Endothelial Progenitor Cells and their production of superoxides as well as the bioavailabiliy of nitric oxide
to assess safety and tolerability of Olmesartan Medoxomil 40 mg in patients with chronic kidney disease. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
* Signed written informed consent * Woman or man aged 18 to 70 years * Chronic Kidney Disease (CKD II-IV) * Endogenous creatinine clearance between 15 ml/min and 90 ml/min. No impending need for dialysis during the study * HbA1C <8% for patients with diabetes mellitus type II * No Autosomal Dominant Polyzystic Kidney Disesase (ADPKD) * No known metabolic diease except diabetes mellitus type II
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E.4 | Principal exclusion criteria |
* Myelodysplastic or –proliferative diseases * Malignant disease diagnosed within the last 5 years * Renal anemia (Hb ≤10,5 g/dl for men or ≤10 g/dl for women) or therapy with rHuEPO or analogs * Therapy with growth factors, e.g. GM-CSF or VEGF * Statin Therapy * Bleeding episodes relevant for Hb within the last 3 months or known gastrointestinal bleeding sources * Foreseeable need for dialysis * Sitting dBP >100 mmHg with standard antihypertensives (incl. ACE Inhibitors or ARB) * Sitting sBP >100 mmHg with standard antihypertensives (incl. ACE Inhibitors or ARB) * Known intolerance of ARBs, e.g. Olmetec®, Diovan®, Lorzaar®, Atacand®, Aprovel®, Mircardis®, Teveten® * Known HIV infection * Systemic chemotherapy or radiotherapy * Chronic infection and/or CRP >10 mg/l at the beginning of the study * Acute cardiovascular episodes * Organ transplants * Pregnant or lactating woman * Woman of childbearing potential without adequate contraception * Psychiatric disease or chronic cerebral attacks * Non-compliance or participation in another clinical study within the last 30 days
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary study end point is the re-endothelialized area after experimental carotid injury in a nude mice model. |
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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 | 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 | 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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
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 | 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 | |
E.8.9.1 | In the Member State concerned days | |