RecruitingPhase 3NCT03789552

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

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Phase 3 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


Sponsor

Tasly Pharmaceuticals, Inc.

Enrollment

765 participants

Start Date

Aug 1, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo capsule and a drug called T89 capsule for people with chronic stable angina pectoris. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGT89 capsule

T89 capsules (75mg)

DRUGPlacebo capsule

Placebo capsules (0mg)


Locations(1)

Southwest Florida Research LLC

Naples, Florida, United States

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NCT03789552