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)
| Facility | City | Province |
|---|---|---|
| Dr. Petr Polasek, MD, Office of | Kelowna | British Columbia |
| The Medical Arts Health Research Group | North Vancouver | British Columbia |
| Victoria Heart Institute Foundation | Victoria | British Columbia |
| Dixie Medical Group | Mississauga | Ontario |
| Bakbak Medicine Professional Corporation | Oshawa | Ontario |
| Heart Care Research | Oshawa | Ontario |
| St. Michael's Hospital | Toronto | Ontario |
| ViaCar Recherche Clinique Inc. | Brossard | Quebec |
| ViaCar Recherche Clinique Inc. | Greenfield Park | Quebec |
| Centre Cardiovasculaire De La Rive-Sud (Ccrs) | Longueuil | Quebec |
| Clinique Sante Cardio MC | Montreal | Quebec |
| Montreal Heart Institute | Montreal | Quebec |
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec | Québec | Quebec |
| Centre de Sante et de Services Sociaux de Trois-Rivieres | Trois-Rivières | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01659580