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.
After signing the consent, patients will enter the single blind qualifying run-in period for
3 weeks. All prophylactic anti-anginal medications will be withdrawn except no more than one
beta blocker or one calcium channel blocker (CCB) to remain. If patients can tolerate the
withdrawal of the multiple anti-anginal medications, the dose of the remained one beta
blocker or one CCB will be kept unchanged until the double-blind treatment period ends. In
this study period, patients will have two exercise tolerance tests (ETTs) on standard Bruce
protocol, conducted one week apart. Sublingual nitroglycerin is allowed for symptomatic
relief of angina attack.
After screening, eligible patients will be randomly assigned to receive one of the three
double-blind treatments: high dose T89 of 300 mg, bid, low dose T89 of 225 mg, bid, or
placebo, in a 1:1:1 ratio. Each patient will be instructed to administer assigned treatment
twice daily for 8 weeks. ETTs will be performed at the end of week 6 and 8 of treatment, or
end of treatment (EOT) if study patient discontinues study prematurely.
Seattle Angina Questionnaire (SAQ) will be used to record patients' quality of life. Clinical
evaluations and adverse event monitoring will be assessed throughout the study. Laboratory
tests will be performed at screening and the designated visits.
Once the treatment period is completed, patients will enter the extended open label safety
assessment period for a further 44 weeks. During this period, all patients will receive T89
at a daily dose of 600 mg, and they can resume their original anti-anginal medications as
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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