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

NCT03789552 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 765

Last updated 2025-04-09

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Stable Angina Pectoris

Interventions

DRUG

T89 capsule

T89 capsules (75mg)

DRUG

Placebo capsule

Placebo capsules (0mg)

Sponsors & Collaborators

  • Tasly Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Henry H Sun, PhD, MD · Tasly Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2026-12-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03789552 on ClinicalTrials.gov