Study design and organization

This study follows the design of a randomized, parallel group, double blind, placebo controlled trial with telmisartan in the initial dose of 40 mg, increased after one week to 80 mg in a single morning dose.

Subjects

The study will include overall 46 healthy volunteers, 20 to 65 years of age, males and females possibly in a 1:1 ratio. The study population will consist of:
1) alpinists (A) group including 10 subjects with high altitude climbing expertise; this group will attempt the ascent to Mt. Everest summit;
2) excursionists (E) groups including the remaining 36 subjects.
The two groups will stay together as far as the advanced base camp (6400 m a.s.l.) for then to divide themselves in the final phase of the ascension to Mt. Everest summit. This last step will be faced only by the group of 10 mountain climber. During the expedition all the members will receive daily, but in absolutely casual way and not identifiable from themselves, a dose of placebo or a dose of 80 mg of telmisartan, the medicine whose effects in high altitude must be studied.