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

Conditions

• Chronic Stable Angina Pectoris

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• T89 capsule — DRUG
  T89 capsules (75mg)
• Placebo capsule — DRUG
  Placebo capsules (0mg)

Study Details

This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group phase 3 clinical study to confirm the safety and efficacy of T89 in patients with stable angina pectoris, with an extended open-label period to evaluate the long-term safety of T89. This study includes three main periods: the first study period 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.

Key Dates

Start date

Aug 1, 2019

Status verified

Apr 2025

Primary completion

Dec 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

765 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: T89 low-dose group
  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.
• Experimental: T89 high-dose group
  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.
• Placebo Comparator: Placebo group
  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.

Primary Outcome Measure

Change in symptom-limited total exercise duration (TED) at trough drug levels on standard Bruce protocol from baseline to Day 57 [ Time Frame: Day 57 (post drug administration from randomization) ]

Central Contacts

• Henry H Sun, PhD, MD
  301-978-3905
  [email protected]
• Ruoling Guo, PhD
  [email protected]

Locations (1)

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