E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study is aimed at the investigation of adaptative physiological mechanisms at high altitude and not at the development of new therapeutic indications. |
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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 | SOC |
E.1.2 | Classification code | 10007541 |
E.1.2 | Term | Cardiac disorders |
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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 study the effect of telmisartan on the cardiovascular, respiratory, neural and metabolic responses to high altitude hypobaric hypoxia |
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E.2.2 | Secondary objectives of the trial |
- to investigate the cardiovascular, neural, endocrine, metabolic, hematologic and molecular effects of hypobaric hypoxia at extreme altitude at various stages of adaptation - to evaluate the acute physiological effects of nonpharmacological interventions potentially useful for the treatment of acute mountain sickness, including continuous positive airway pressure (CPAP) and controlled slow breathing (SlowB) to explore the relationship between changes in biological parameters and changes in meteorological parameters such as temperature, humidity and UV radiation exposure. Aims of this subproject will also be to monitor/forecast weather and microclimatic variables near the ground at different altitude, and to predict the physical/physiological performance in those environments by the assessments of thermal balances during different physical activities. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: Group A: male and female volunteers aged 20 to 65 years with high altitude climbing expertise (including professional climbers) informed consent to study procedures Group E male and female volunteers residing at low altitude aged 20 to 65 years informed consent to study procedures |
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E.4 | Principal exclusion criteria |
Exclusion criteria: chronic therapy with cardiovascular drugs, beta-mimetics and other drugs that may interfere with the physiological mechanisms under study or may be unsafe in high altitude conditions pregnancy repeated exposures to altitudes >3000 m a.s.l. in the 8 months preceding the expedition history of severe AMS forms including HAPE and HACE relevant chronic diseases (any chronic cardiovascular or renal disease, diseases that reduce functional capacity, infectious diseases) relevant diseases in the past (pneumothorax, major thoracic traumas, major surgical procedures etc.) |
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E.5 End points |
E.5.1 | Primary end point(s) |
changes in bloode pressure ,heart rate, respiratory rate, oxygen saturation and metabolic parameters |
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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 | 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 | 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 | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |