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 | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001580 |
E.1.2 | Term | Albuminuria |
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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 primary objective of the study is urinary albumin excretion measured as albumin to creatinine ratio from spot urine. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are 24 hour albumin excretion, 24-h ambulatory blood pressure, oral glucose tolerance test, adiponectin, HOMA index, lipid profile, CRP. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Albumin excretion > 3,9 mg/g creatinine in men and > 7,5 mg/g creatinine in women confirmed on two occasions. Age >=18 and <=75 years |
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E.4 | Principal exclusion criteria |
• Antihypertensive treatment or blood pressure >= 140/90 mmHg • Antidiabetic treatment or blood glucose ≥ 126 mg/dl • Blood pressure <120/80 mmHg • Treatment with lipid lowering drugs • Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. • Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study. • Treatment with any investigational product in the last 3 months before study entry • Pregnancy • Breast-feeding • Childbearing potential (i.e. ovulating, pre-menopausal, not surgically sterile) • History of hypersensitivity to the investigational products or to drugs with similar chemical structures • Treatment with other ARBs in the last 4 weeks before study entry • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol • Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult • History of drug or alcohol abuse • Impaired hepatic function, as shown by transaminases higher than the double of the upper normal limit • Impaired renal function, as shown by estimated GFR (abbreviated MDRD formula) <60 ml/min • any renal disease
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E.5 End points |
E.5.1 | Primary end point(s) |
urinary albumin excretion measured as albumin to creatinine ratio from spot urine |
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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 | No |
E.6.5 | Efficacy | No |
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) | 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 | No |
E.8.1.6 | Cross over | Yes |
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
| 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |