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Herbal Medicine
T89 capsule for Chronic Stable Angina
Phase 3
Waitlist Available
Research Sponsored by Tasly Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 57 (post drug administration from randomization)
Awards & highlights
Summary
This trial tests T89, a new medication for people with stable angina. It aims to see if T89 can help the heart get more oxygen during exercise, reducing chest pain and improving exercise ability. The study evaluates the safety and effectiveness of T89 over time.
Eligible Conditions
- Chronic Stable Angina
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 57 (post drug administration from randomization)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 57 (post drug administration from randomization)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in symptom-limited total exercise duration (TED) at trough drug levels on standard Bruce protocol from baseline to Day 57
Secondary study objectives
Change in symptom-limited total exercise duration (TED) at trough drug levels on standard Bruce protocol from baseline to Day 43
Change in time to 1 mm ST depression during ETT from baseline to Day 57
Change in time to onset of angina during ETT from baseline to Day 57
+4 moreOther study objectives
Frequency and severity of adverse events and serious adverse events
Notable laboratory abnormalities which are treatment-emergent
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: T89 low-dose groupExperimental Treatment2 Interventions
T89 capsule is a botanical drug containing 75mg active substance which is the water extract of Danshen and Sanqi. Placebo capsule does not contain any amount of active substance.
Subjects in this group will use three T89 capsules and one Placebo capsule each time by oral administration twice daily for 8 weeks.
Group II: T89 high-dose groupExperimental Treatment1 Intervention
T89 capsule is a botanical drug containing 75mg active substance which is the water extract of Danshen and Sanqi.
Subjects in this group will use four T89 capsules each time by oral administration twice daily for 8 weeks.
Group III: Placebo groupPlacebo Group1 Intervention
Placebo capsule does not contain any amount of active substance. Subjects in this group will use four Placebo capsules each time by oral administration twice daily for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo capsule
2015
Completed Phase 4
~5270
T89 capsule
2018
Completed Phase 3
~990
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Who is running the clinical trial?
Tasly Pharmaceuticals, Inc.Lead Sponsor
22 Previous Clinical Trials
4,817 Total Patients Enrolled
Henry H Sun, PhD, MDStudy ChairTasly Pharmaceuticals, Inc.
1 Previous Clinical Trials
853 Total Patients Enrolled
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