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Phase III Trial of Dantonic® (T89) Capsule to Prevent and Treat Stable Angina

CompletedPhase 3NCT01659580
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

This phase III study is designed as a double blind, randomized, multi-nation, multi-center, placebo controlled clinical research, which aims to evaluate the safety and efficacy of Dantonic® (T89) in patients with chronic stable angina pectoris.

Study details

Official title
Phase III Confirmatory Trial to Confirm the Anti-anginal Effect of Dantonic® (T89) in Patients With Chronic Stable Angina
Conditions
Interventions
  • Drug: T89 high dose
  • Drug: T89 Low dose
  • Drug: Sanqi+Bingpian
  • Drug: Placebo
Sponsor
Tasly Pharmaceuticals, Inc.
Start date
2012-08
Primary completion
2016-12
Sex
All
Age range
from 20 Years to 80 Years
Results posted
No results posted in this snapshot
Countries
Belarus, Canada, Georgia, Mexico, Russia, Ukraine, United States
Total sites listed
94

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Written informed consent. 2. Males and females between the ages of 20 and 80 years. 3. Females of childbearing potential must have a negative pregnancy test, not be breast feeding and established on a method of contraception that in the investigator's opinion is acceptable. Females must agree to remain on their established method of contraception through their participation in the study and for 14 days following the last dose of study drug. 4. Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrolment) of myocardial infarction or significant coronary artery disease with noninvasive or angiographic confirmation. 5. Symptoms that support the diagnosis of chronic angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph (ECG) changes. 6. Moderate angina pectoris (Class II or III, Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System). 7. Patient whose symptom-limited Total Exercise Duration (TED) is between 3 to 7 minutes in Exercise Tolerance Test (ETT) on Standard Bruce Protocol, and symptom-limited TED on two screen examinations (Day -7 and 0) in which the shorter is within 85% of the longer . 8. Patient has been on one beta-blocker or on one calcium-channel blocker for at least 14 days prior to dosing of study medication and can remain on this treatment throughout the study as background anti-anginal treatment. Short-acting nitroglycerin for on-demand use is allowed for all eligible patients. 9. Understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the verbal rating scales and diary cards. Exclusion Criteria: 1. With contraindication to, unable to, or with other co-morbidities that may prevent or interfere with the ability to perform treadmill ETT (including, but not limited to: pulmonary hypertension, functionally limiting COPD (chronic obstructive pulmonary disease), history of pulmonary tuberculosis, prior hospitalization for acute exacerbation of chronic lung disease, home oxygen use, chronic oral steroid therapy that can limit exercise capacity, functionally limiting peripheral artery disease, etc.). 2. Presence of electrocardiographic or other abnormalities/factors that could interfere with exercise electrocardiograph interpretation or may lead to a false positive stress test (e.g., pre-exercise horizontal or down-sloping ST segm…

Canadian sites (14)

FacilityCityProvince
Dr. Petr Polasek, MD, Office ofKelownaBritish Columbia
The Medical Arts Health Research GroupNorth VancouverBritish Columbia
Victoria Heart Institute FoundationVictoriaBritish Columbia
Dixie Medical GroupMississaugaOntario
Bakbak Medicine Professional CorporationOshawaOntario
Heart Care ResearchOshawaOntario
St. Michael's HospitalTorontoOntario
ViaCar Recherche Clinique Inc.BrossardQuebec
ViaCar Recherche Clinique Inc.Greenfield ParkQuebec
Centre Cardiovasculaire De La Rive-Sud (Ccrs)LongueuilQuebec
Clinique Sante Cardio MCMontrealQuebec
Montreal Heart InstituteMontrealQuebec
Institut Universitaire de Cardiologie et de Pneumologie de QuebecQuébecQuebec
Centre de Sante et de Services Sociaux de Trois-RivieresTrois-RivièresQuebec
Canadian sites for NCT01659580KelownaNorth VancouverVictoriaMississaugaOshawaTorontoBrossardGreenfield Park
Canadian sites for NCT01659580. 12 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01659580