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

Who is this study for? Adult patients with Stable Angina
What treatments are being studied? T89
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Willing to participate and sign a written informed consent

• Males and females ≥ 18 and ≤90 years old.

• Medical history of chronic stable angina triggered by physical effort and relieved by rest or sublingual nitroglycerin.

• Patients who agree and in the opinion of the investigator are able to withdraw all non-beta blocker and all non-calcium channel blocker anti-anginal medications. For those subjects who are on beta blockers and/or calcium channel blockers, they are able to keep only one beta blocker or one calcium channel blocker (acceptable calcium channel blocker: amlodipine, diltiazem, verapamil or nicardipine), but not both, and subjects agree and are expected to be able to remain on this treatment regimen from Day -21 until the completion of the double-blind period in the opinion of the investigator.

⁃ 1) For patients who have to modify their anti-anginal treatment regimen to meet the above qualification criteria, health care provider who is responsible for the patient's cardiac care (if this is not the study doctor) must provide a form of agreement (verbal conversation, phone call, in writing or shown as referral) to the PI before the treatment modification.

⁃ 2) For patients who are not on beta blocker or calcium channel blocker or other antianginal medications, there is no requirement to start on antianginal medication.

• \*nitroglycerin tablets, only those provided by sponsor, are allowed to be used for on-demand symptomatic relief of angina during the qualifying and treatment periods to ensure an accurate calculation of consumption.

• Documented history of coronary artery disease with one or more of the following conditions:

⁃ 1) History of previous myocardial infarction (previous MI that occurred and was diagnosed at least 3 months prior to start of screening).

⁃ 2) Ischemic heart disease determined by stress myocardial imaging examination (including nuclear stress test, cardiac stress MRI and echocardiography stress test).

⁃ 3) Clinically significant coronary stenosis ≥50% in any vessel detected by coronary angiography (or coronary CT angiography).

• Understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the Seattle Angina Questionnaire rating scales and diary cards.

• Women of child bearing potential: Female patients of child-bearing potential or male patients with partners of child-bearing potential must use appropriate birth control from the start of screening, until 3 months after the last dose of study medication. Female patients of child bearing potential must have negative pregnancy tests at screening visit \[Day -21, quantitative serum human chorionic gonadotropin (β-hCG test)\] and randomization visit (Day 1, urine pregnancy test).

• Patient must experience two or more angina episodes from Day-14 to Day 1, as the baseline frequency of angina. At least two of the angina episodes must be recorded by WCM (Other written forms of recording/reporting angina episodes may be acceptable only in situations and times that recording by WCM is impractical. In addition, patients are allowed to use short acting nitroglycerin for relief of angina).

• To be qualified, patients must have two qualifying ETTs on standard Bruce protocol on Day- 7 and Day 1. The qualifying ETTs are:

‣ ETTs must meet the positive ETT criteria;

⁃ Total exercise duration (TED) of the positive ETT is between 3-12 minutes of exercise;

⁃ The difference in TED between the two ETTs must not exceed 15% of the longer one.

∙ For the qualifying ETTs, in patients with permitted baseline ST-segment depression at rest (\<1 mm at 80 msec after the J point), qualifying ST-segment depression during ETT will be defined as additional ST-segment depression ≥1 mm (at 80 msec after the J point) below the resting value.

Locations
United States
Florida
Southwest Florida Research LLC
RECRUITING
Naples
Contact Information
Primary
Henry H Sun, PhD, MD
HSun@taslyUS.com
301-978-3905
Backup
Ruoling Guo, PhD
RGuo@taslyUS.com
Time Frame
Start Date: 2019-08-01
Estimated Completion Date: 2027-03
Participants
Target number of participants: 765
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Tasly Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov