Safety and Efficacy of T89 in the Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)
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ClinicalTrials.gov Identifier: NCT04993729 |
Recruitment Status :
Recruiting
First Posted : August 6, 2021
Last Update Posted : May 6, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | July 14, 2021 | ||||
First Posted Date ICMJE | August 6, 2021 | ||||
Last Update Posted Date | May 6, 2023 | ||||
Actual Study Start Date ICMJE | July 21, 2021 | ||||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change of baseline corrected mean LLSS score on Day 4 morning (next mornings after arrival at high altitude) between T89 and placebo groups. [ Time Frame: Baseline and day 4 ] 2018 Lake Louise Scoring System (LLSS) score [0-12] will be used in this primary outcome assessment. The higher LLSS scores mean the worse symptoms of AMS. Baseline will be the average of LLSS scores on Day 2 and the one on Day 3 before breakfast.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy of T89 in the Prevention and Treatment of Adults With Acute Mountain Sickness (AMS) | ||||
Official Title ICMJE | A Multicenter, Double-blind, Randomized and Placebo-controlled Pivotal Phase 3 Study to Evaluate the Safety and Efficacy of T89 in the Prevention and Treatment of Acute Mountain Sickness (AMS) After Rapid Ascent | ||||
Brief 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. | ||||
Detailed Description | Acute mountain sickness (AMS) is a common ailment in people venturing over 2,500 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 with a cluster of nonspecific symptoms including headache and one of the following: gastrointestinal symptoms, fatigue and/or weakness, dizziness/ lightheadedness or difficulty sleeping. T89 capsule is a modernized industrialized version of a traditional Chinese herbal medicine. It is a botanical drug product for oral use. Previous clinical studies showed T89 has substantial benefits in the prevention or amelioration of symptoms associated with acute mountain sickness (AMS).This is double-blind, randomized, placebo controlled pivotal phase 3 study. After informed consent is obtained, eligible subjects will be randomized to one of the 3 study groups (T89 high dose, T89 low dose and placebo control). The study drug will be given orally for 5 days (2 days at sea level and 3 days at high altitude). The clinical assessment of Lake Louise Scoring System (LLSS), blood oxygen saturation, the exercise tolerance, blood pressure and heart rate will be performed at sea level and altitude. A total of 846 subjects will be enrolled with 282 subjects in each treatment arm, and a minimum of 756 subjects are expected to complete the study. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Acute Mountain Sickness (AMS) | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
846 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | April 2024 | ||||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04993729 | ||||
Other Study ID Numbers ICMJE | T89-31-AMS | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Tasly Pharmaceuticals, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Tasly Pharmaceuticals, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Tasly Pharmaceuticals, Inc. | ||||
Verification Date | May 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |