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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

Study Summary

This trial is studying if a drug called T89 is effective and safe for people with stable angina. It is a 3-week single-blind qualifying run-in period to screen eligible stable angina patients by exercise tolerance test (ETT). The second study period is a 8-week double-blind treatment period to evaluate the efficacy and safety of T89 in patients with stable angina by ETT. And, the last study period is a 44-week open-label period to observe long-term use safety of T89.

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)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in symptom-limited total exercise duration (TED) at trough drug levels on standard Bruce protocol from baseline to Day 57

Secondary outcome measures

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 outcome measures

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

T89 capsule

2018

Completed Phase 2

~140

Placebo capsule

2015

Completed Phase 4

~5270

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Tasly Pharmaceuticals, Inc.Lead Sponsor

22 Previous Clinical Trials

4,810 Total Patients Enrolled

Henry H Sun, PhD, MDStudy ChairTasly Pharmaceuticals, Inc.

1 Previous Clinical Trials

846 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can patients over the age of 35 enroll in this clinical trial?

"This study allows for a broad age range of participants, with the youngest being 18 and the oldest being 90."

Answered by AI

Are there any more open slots for participants in this clinical trial?

"That is accurate. The listing on clinicaltrials.gov indicates that the trial is ongoing and currently looking for 765 patients at a single location. The trial was first posted on August 1st, 2019 and was last updated on January 11th, 2021."

Answered by AI

Do I fit the profile of patients this trial is seeking?

"This trial is looking for 765 individuals who have angina and meet the following criteria: *They can only use nitroglycerin tablets for symptomatic relief of angina during the qualifying and treatment periods to ensure an accurate calculation of consumption., 5.3) They have a clinically significant coronary stenosis ≥50% in any vessel detected by coronary angiography (or coronary CT angiography)., They are willing to participate and sign a written informed consent, They are males and females ≥ 18 and ≤90 years old., They have a medical history of chronic stable angina triggered by physical effort and relieved by rest or subling"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Outcome Research to Confirm the Anti-anginal Effect of T89 in Patients With Stable Angina". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03789552.