Safety and Efficacy of T89 in the Prevention and Treatment of Adults With Acute Mountain Sickness… (NCT04993729) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of T89 in the Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)
United States, China853 participantsStarted 2021-07-21
Plain-language summary
The specific aim of this double blind, randomized phase III trial is to evaluate the safety and efficacy of T89 in preventing Acute Mountain Sickness (AMS) and relieving the symptoms of AMS after rapid ascent.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Healthy volunteers: ages 18 - 55 years old;
✓. Primary residence elevation of 2,461 ft (750m) or lower;
✓. Not ascending to altitude \>10,000 ft within 4 months prior to screening;
✓. Females of childbearing potential must have a negative pregnancy test and established on a method of contraception that in the investigator's opinion is acceptable. Females must agree to remain on their established method of contraception from the time of the screening visit and throughout the study period;
✓. Willing to participate voluntarily and sign a written informed consent.
Exclusion criteria
✕. Subjects with medical history of cardiovascular, cerebrovascular diseases or asthma; uncontrolled hypertension with SBP\>140 and or DBP\>90 mmHg;
✕. Subjects with current and clinically significant respiratory system disease, digestive disease, liver disease, central nervous system disease, psychiatric disease, metabolic disease, renal disease, acute infection or anemia, or who test positive for COVID-19 (COVID testing will be performed, not per study requirement, but in compliance with local law or policy, and subject with known positive for COVID-19 will be excluded).
✕. Total LLSS score (LLSS score) is ≥2 at any check point during screening period;
✕. Blood oxygen saturation (SpO2), preferably tested on the left-hand index finger, is less than 95% at screening visits;
✕. Subjects with abnormal renal or liver function with clinical significance (ALT or AST \> 2×ULN, Creatinine \> ULN) at screening visit;
What they're measuring
1
Change of baseline corrected mean LLSS score on Day 4 morning (next mornings after arrival at high altitude) between T89 and placebo groups.
✕. Subjects with primary (migraine, tension-type headache, and cluster headache etc.) or secondary headaches (headache related to infection, vascular disease etc.) within one month at screening;
✕. Surgery or blood donation within 3 months prior to screening;