T89 in Prevention and Treatment of Acute Mountain Sickness (AMS) During Rapid Ascent — T89-AMS  

Acute Mountain Sickness Clinical Trial

Official title: A Double-blind, Randomized and Placebo-controlled Phase 2 Study to Evaluate the Safety and Efficacy of T89 in Prevention and Treatment of Acute Mountain Sickness (AMS) During Rapid Ascent

Status Recruiting

Clinical Trial Summary

To evaluate the safety and efficacy of T89 in preventing Acute Mountain Sickness (AMS) and relieving the symptoms of AMS during rapid ascent.

Clinical Trial Description

Acute mountain sickness (AMS) is a common ailment in people venturing over 2500 meters altitude. It is a pathological effect of high altitude on humans, caused by acute exposure to low partial pressure of oxygen at high altitude. It presents as a collection of nonspecific symptoms, acquired at high altitude or in low air pressure, including headache and one of the following: gastrointestinal symptoms, fatigue and/or weakness, dizziness/ lightheadedness or difficulty sleeping. Severity and incidence of these conditions depend on the rate of ascent, elevation obtained, duration of altitude exposure, physical exertion, and inherent genetic susceptibility. Pilgrims to high altitudes are at an added risk since they are unaware and they gain height faster than the recommendations. The underlying pathophysiology of AMS remains poorly defined, but some data support the role of increased fluid retention, which may contribute to cerebral over perfusion, endothelial leakage, and eventual subclinical cerebral edema.

T89 capsule is a modernized industrialized version of a traditional Chinese herbal medicine. It is a botanical drug product for oral use. The drug substance is the water extract of Danshen (Radix Saliva Miltiorrhiza Bge., RSM) and Sanqi (Radix Notoginseng, RN). T89 capsule also contains Bingpian (Borneol) which is acting as an absorption enhancer.

T89 is currently used internationally for the treatment of chronic stable angina pectoris due to coronary heart disease. T89 was approved for marketing as a drug by China Food and Drug Administration (CFDA) in 1993. The estimated exposure population is more than 240 million person·month calculated by sales data from 1995 to 2016. The global market of T89 is continuously expanding. Since the first launch in Vietnam in 2000, Cardiotonic Pill and Cardiotonic Capsule have been legally marketed in 32 countries or regions as prescription drug, OTC, dietary supplement, or complementary medicine. For overseas market, the estimated exposure population is about 1 million person·month calculated by sales volume.

In the United States, T89 was approved as an investigational new drug indicated for the prevention and treatment of the reoccurrence of angina pectoris in patient with confirmed chronic stable angina in 2006. A pivotal global Phase 3 clinical study was completed in 2016, with a total 1004 patients enrolled in 7 countries.

In recent years, several literatures and clinical studies have demonstrated that T89 showed substantial benefits in the prevention or amelioration of symptoms associated with acute mountain sickness (AMS), including nausea, vomiting, headache, dizziness, fatigue, and sleep disturbance. Such efficacy was also verified in terms of AMS incidence rate and symptom severity from a recent pilot clinical study conducted by the sponsor in Tibet, China. ;

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness

• NCT number: NCT03621410
• Study type: Interventional
• Source: University of California, San Francisco
• Contact: Koa Gudelunas
• Phone: 4154768984
• Email: dantonic_ams_trial@ucsf.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2018
• Completion date: October 2019