NCT01465971 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Jackson SJ, Varley J, Sellers C, Josephs K, Codrington L, Duke G, Njelekela MA, Drummond G, Sutherland AI, Thompson AA, Baillie JK
Incidence and predictors of acute mountain sickness among trekkers on Mount Kilimanjaro. High Alt Med Biol. 2010 Fall;11(3):217-22. doi: 10.1089/ham.2010.1003.
Szymczak RK, Sitek EJ, Slawek JW, Basinski A, Sieminski M, Wieczorek D
Subjective sleep quality alterations at high altitude. Wilderness Environ Med. 2009 Winter;20(4):305-10. doi: 10.1580/1080-6032-020.004.0305.

Monitoring of the Cerebral Tissue Oxygenation and Perfusion in the Adapting Climber During the Sleep in High Altitude

Clinical trial NCT01465971 - References