E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Influence of Telmisartan on insulin resistance, hypertension, non-alcoholic fatty liver |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020772 |
E.1.2 | Term | Hypertension |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052066 |
E.1.2 | Term | Metabolic syndrome |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022489 |
E.1.2 | Term | Insulin resistance |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016261 |
E.1.2 | Term | Fatty liver |
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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 |
Improvement of insulin resistance reflected by normalized or increased ISI-Matsuda (> 4) 6 months after treatment with Telmisartan |
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E.2.2 | Secondary objectives of the trial |
Improvement of insulin resistance reflected by normalized or increased ISI-Matsuda (> 4) 3 months after treatment with Telmisartan Improvement of insulin resistance reflected by normalized or decreased HOMA-IR (< 2) 3 and 6 months after treatment with Telmisartan Improvement of hypertension measured by blood pressure over 24 h Improvement / normalization of the liver enzymes (gamma-GT, ALT) measured by their serum concentrations Improvement / normalization of tissue structure of liver analyzed by sonography Improvement / normalization of the blood lipids measured by serum concentrations of triglycerids, total cholesterol, HDL and LDL Improvement / normalization of tissue structure of liver analyzed by sonographyferric marker measured by serum concentrations of ferritin, iron and transferrin Improvement / normalization of Body mass index and abdominal girth Improvement / normalization of uric acid measured by the serum concentration |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- male or female adult patients aged 18 – 80 years inclusive, legally competent - written informed consent - presence of arterial hypertension - evidence of increased HOMA-IR >2 - evidence of decreased ISI-Matsuda <4 - presence of increased liver enzymes (ALT and/or gamma-GT) - presence of fatty liver indicated by sonography - ethnic background: caucasian - presence of negative pregnancy test
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E.4 | Principal exclusion criteria |
- other liver diseases: e.g. virus-induced hepatitis, hemochromatosis - presence of servere increased liver enzymes (ALT > 4 µkat/l; AST > 4 µkat/l and gamma-GT > 10 µkat/l) as an evidence for serious liver diseases - increased AST enzym activity in comparison to ALT enzym activity as an evidence for an alcoholic fatty liver disease (AFLD) - obstructive disease of bile ducts and cholestasis - pretreatment of hypertension with sartans - chronic infections resp. presence of increased CRP serum concentration - hypersensitivity to telmisartan or another ingredient of medicinal product - hereditary fructose intolerance based on sorbitol in medicinal product - presence of an angioneurotic edema during former treatment with ACE-inhibitors or angiotensin-II-receptor-antagonists - presence of manifest diabetes mellitus type 2 - concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days - Pregnancy, lactation period or female patients seeking to become pregnant during interventional period - Low compliance or inability to understand instructions/study documents |
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E.5 End points |
E.5.1 | Primary end point(s) |
Normalization / Increasing of ISI-Matsuda |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | 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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last patient out: 07/2013 |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |