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NCT01659580 · ClinicalTrials.gov registry record · Phase 3
Phase III Trial of Dantonic® (T89) Capsule to Prevent and Treat Stable Angina
A Phase 3 study of Angina Pectoris, sponsored by Tasly Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,004
- Enrollment target
- 20
- Study locations
NCT01659580: Completed Phase 3 study of Angina Pectoris, sponsored by Tasly Pharmaceuticals.
NCT01659580 is a Phase 3 study of Angina Pectoris that has completed, run by Tasly Pharmaceuticals. The registered enrollment target is 1,004 participants, above the 803-participant average among 9 other Angina Pectoris trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01659580, a Phase 3 study of Angina Pectoris, has completed, sponsored by Tasly Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,004 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The change of symptom-limited Total Exercise Duration (TED) at trough drug levels at the end of the 4th week of treatment from screen baseline on Standard Bruce Protocol compared with placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG T89 high dose
- DRUG T89 Low dose
- DRUG Sanqi+Bingpian
Study Locations (20)
Florida
- Jacksonville Center for Clinical Research - Jacksonville
- Brevard Cardiovascular Research Associates - Merritt
- SouthCoast Research Center, Inc - Miami
- Molecular Imaging Research and Clinical Trials - Miami
- Integrity Clinical Trials - Miami
- NewPhase Clinical Trials, Inc. - Miami Beach
- Peninsula Research, Inc. - Ormond Beach
- Cardiovascular Center of Sarasota - Sarasota
- Jedidiah Clinical Research - Tampa
California
- Beaver Medical Clinic - Banning
- Foundation for Cardiovascular Medicine - La Jolla
- Precision Research Institute - National City
- Paradigm Clinical Research Institute, Inc. - Torrance
- Harbor-UCLA Medical Center - Torrance
Georgia
- Athens Heart Center - Athens
- Atlanta Clinical Research Center - Atlanta
- Ellipsis Research - Atlanta
Arkansas
- Cardiology and Medicine Clinic - Little Rock
Kentucky
- Central Cardiology - Campbellsville
Louisiana
- Alexandria Cardiology Clinic - Alexandria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,004 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
What the finished NCT01659580 record still lists
NCT01659580 is an interventional study that assigns participants to a tested intervention. Its 1,004 participants enrollment target places it among the larger protocols in the corpus, above the 803-participant average among 9 other Angina Pectoris trials with a reported enrollment target (25% higher).
The record links to 1 condition, with Angina Pectoris appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01659580 names 20 study sites across 6 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01659580 about?
NCT01659580 is a clinical study titled "Phase III Trial of Dantonic® (T89) Capsule to Prevent and Treat Stable Angina". 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.
What is the current status of trial NCT01659580?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,004 participants. The study started on 2012-08. Estimated completion is 2016-12.
What conditions does trial NCT01659580 study?
This clinical trial studies the following conditions: Angina Pectoris.
What interventions are being tested in trial NCT01659580?
The interventions under investigation include: Placebo (DRUG), T89 high dose (DRUG), T89 Low dose (DRUG), Sanqi+Bingpian (DRUG).
Who is sponsoring clinical trial NCT01659580?
This trial is sponsored by Tasly Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01659580 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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