Phase II Multi-Center Study of T89 to Treat Chronic Stable Angina
T89 phase 2
A Phase II, Double Blind, Placebo-controlled, Randominzed, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of T89 in Patient With Chronic Stable Angina Pectoris
1 other identifier
interventional
124
1 country
15
Brief Summary
The purpose of this study is to determine the anti-angina effect and dose response of T89, a 2-herb botanical drug product, in patients with chronic stable angina pectoris in the United States.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2007
Typical duration for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 24, 2008
CompletedFirst Posted
Study publicly available on registry
November 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedDecember 12, 2012
December 1, 2012
2.8 years
November 24, 2008
December 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Exercise Duration (TED) change from screen baseline value in Exercise Tolerance Test (ETT) on Standard Bruce Protocol at trough drug levels at the end of the 4th and 8th week of treatment compared to placebo.
12 weeks
Secondary Outcomes (1)
Frequency of weekly angina episodes
12 weeks
Study Arms (3)
Low dose
EXPERIMENTAL2 capsules of T89 with 1 placebo capsule each time, twice daily. The daily dose is 250 mg.
High dose
EXPERIMENTAL3 capsules of T89 each time, twice daily. The daily dose is 375 mg
Placebo
PLACEBO COMPARATOR3 placebo capsules (PC) each time, twice per day. The daily dose is 0 mg.
Interventions
A two-herb botanical drug product in 62.5mg capsule formulation. It is to be used as 125mg or 187.5mg twice daily.
Eligibility Criteria
You may qualify if:
- Patient must be between the ages of 18 and 80 years.
- 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.
- Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrollment) of myocardial infarction or significant coronary artery disease with noninvasive or angiographic confirmation.
- 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.
- Moderate angina pectoris (Class II or Class III, Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System)
- Naive patient or patient who's Total Exercise Duration (TED) is between 3 to 7 minutes in ETT on Standard Bruce Protocol, and the difference in TED must be no more than 15% between the two screen examinations on day -7 and day 0
- All anti-angina regimen (except short-acting nitroglycerin, and one beta-blocker or calcium channel blocker), warfarin or other oral anticoagulants which were used prior to this initial visit can be discontinued.
- Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the verbal rating scales and diary cards.
- Patient must be able to give voluntary written informed consent.
You may not qualify if:
- With contraindication to perform treadmill Exercise Tolerance Test (ETT).
- Pre-exercise ST-segment depression of at least 1 mm in any lead, left bundle branch block, digoxin therapy, Left Ventricular Hypertrophy (LVH) and Wolff-Parkinson-White (WPW) syndrome or other factors that could interfere with exercise electrocardiograph interpretation.
- Clinically significant arrhythmias or atrioventricular conduction block greater than first degree.
- Clinically significant co-morbidities, including hepatic or renal dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, history of cerebral hemorrhage, or seizure disorders that required anticonvulsant medication.
- History of congestive heart failure, unstable angina, severe valvular disease, severe hypertension, severe anemia, suspected or known dissecting aneurysm, acute myocarditis or pericarditis, thrombophlebitis or pulmonary embolism or recent myocardial infarction within three months of study entry.
- History of bleeding diathesis, or is on warfarin.
- Implanted pacemaker.
- Aspirin and/or statins started less than 14 days prior to the signing of informed consent.
- Pregnancy or lactation.
- Inability to discontinue existing chronic nitrate regimen (e.g. long acting nitroglycerin) and allow only short-acting nitroglycerin and one beta-blocker or calcium channel blocker.
- Clinical trials/experimental medication:
- Participation in any other clinical trial or receipt of an investigational drug within 90 days prior to initial visit.
- Those patients unable, in the opinion of the investigator, to comply fully with the trial requirements.
- Previous participation in this study.
- Substance abuse. Patients with a recent history (within the last 2 years) of alcoholism or known drug dependence.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Paradigm Clinical, Inc.
Tucson, Arizona, 85705, United States
Robert M. Karns, A Medical Corporation
Beverly Hills, California, 90211, United States
Inland Heart Doctors
Corona, California, 92879, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, 33319, United States
Cardiovascular Research Center of South Florida
Miami, Florida, 33173, United States
Alexandria Cardiology Clinic
Alexandria, Louisiana, 71301, United States
Great Lakes Research Group, Inc
Bay City, Michigan, 48706, United States
Marc Kozinn Associates
Williamsville, New York, 14221, United States
Oklahoma Cardiovascular & Hypertension
Oklahoma City, Oklahoma, 73132, United States
Three Rivers Medical Associates
Columbia, South Carolina, 29201, United States
East Texas Cardiology
Houston, Texas, 77002, United States
Northwest Houston Cardiology
Houston, Texas, 77070, United States
Northwest Heart Center
Tomball, Texas, 77375, United States
National Clinical Research-Norfolk, Inc
Norfolk, Virginia, 23502, United States
Gemini Scientific, LLC
Madison, Wisconsin, 53719, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jason Zhixin Guo, MD
Tasly Pharmaceuticals Co. Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2008
First Posted
November 25, 2008
Study Start
February 1, 2007
Primary Completion
December 1, 2009
Study Completion
January 1, 2010
Last Updated
December 12, 2012
Record last verified: 2012-12