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Herbal Medicine

Outcome Research to Confirm the Anti-anginal Effect of T89 in Patients With 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

Pivotal Trial

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

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 57 (post drug administration from randomization) for reporting.

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 more

Other study objectives

Frequency and severity of adverse events and serious adverse events

Notable laboratory abnormalities which are treatment-emergent

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~5340

T89 capsule

2018

Completed Phase 3

~990