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Trial registered on ANZCTR


Registration number
ACTRN12609000044224
Ethics application status
Approved
Date submitted
26/11/2008
Date registered
20/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase II, Double Blind, Placebo-controlled, Randomized, Multi-Center, Parallel Group Study to Evaluate The Efficacy and Safety of T89, drug name: Dantonic 'Registered trade mark' in Patients with Chronic Stable Angina Pectoris
Scientific title
A Phase II, Study to Evaluate The Efficacy and Safety of Dantonic 'Registered trade mark' in Patients with Chronic Stable Angina Pectoris
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Stable Angina Pectoris 4029 0
Angina 4030 0
Condition category
Condition code
Cardiovascular 4233 4233 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This prospective, double-blind, randomized, multi-center, and placebo-controlled, 2 parallel group phase II trial is to investigate the anti-angina effect of T89 at 187.5 mg, administered orally every 12 hours (daily dose 375 mg) for 8 weeks, while all other concurrent medications for angina pectoris are discontinued except short-acting nitrates (taken as required by patient), beta-blockers or calcium channel blockers, in its ability to enhance exercise tolerance in patients with chronic stable angina pectoris. Exercise Tolerance Tests (ETTs), Safety checks and frequency of Angina.
Intervention code [1] 3827 0
Treatment: Drugs
Comparator / control treatment
Placebo (Sugar pill)
The Placebo group will take 3 capsules of placebo twice a day for 8 weeks administered orally.
Control group
Placebo

Outcomes
Primary outcome [1] 5121 0
The primary objective of this study is to determine the anti-angina effect of T89 in patients with chronic stable angina pectoris measured by the prolongation of Total Exercise Duration in ETT seen when performing a Standard Bruce Protocol.
Timepoint [1] 5121 0
The change of Total Exercise Duration (TED) during ETT using the Standard Bruce Protocol, from baseline, at the time of trough drug levels on weeks 4 and 8, compared to placebo.
Secondary outcome [1] 8624 0
The secondary objectives are to evaluate the safety and tolerability of T89 in patients with chronic stable angina pectoris.
Timepoint [1] 8624 0
1. Change in TED during Exercise Tolerance Tests (ETT) at peak drug levels, using Standard Bruce Protocol, from baseline to weeks 4 and 8 compared to placebo.

2. Change in time to onset of angina during ETT using Standard Bruce Protocol, from baseline to weeks 4 and 8 compared to placebo.

3. Change in time to 0.1 mV ST depression during ETT using Standard Bruce Protocol, from baseline to weeks 4 and 8 compared to placebo.

4. Change in frequency of weekly angina episodes, from baseline to weeks 4 and 8 compared to placebo.

5. Change in weekly on-demand short-acting nitroglycerin consumption, from baseline to weeks 4 and 8 compared to placebo.

6. Change in Quality of Life (QoL) assessment scores using Seattle Angina Questionnaire, from baseline to weeks 4 and 8 compared to placebo.

Specific angina and general medical history will be assessed and recorded for the following body systems: Skin; Head, Ears, Eyes, Nose, Throat; Respiratory; Cardiovascular; Genitourinary/Renal; Gastrointestinal; Endocrine/Metabolic; Neurological; Haematopoietic and Lymphopoietic; Hepatic/Bilary; Musculoskeletal; Psychiatric; Allergies; any other relevant history. Medical History will be recorded up until the first dose of study drug.
PHYSICAL EXAMINATION
On days -14, -7, 0, 7, 14, 28, 56, a thorough physical examination including vital signs (Blood Pressure and Heart Rate) will be carried out covering the following Body systems: General Appearance; Head, Ears, Eyes, Nose, Throat; Lungs/Chest; Heart; Abdomen; Musculoskeletal and Extremities; Neurologic; Vascular/Lymphatic; Skin; Genitourinary; Endocrine and Metabolic, any other relevant findings will be included. After the treatment has started, any new or changed physical examination finding will be noted as an AE on the appropriate CRF page(s). Whenever possible, the underlying diagnosis should be listed in lieu of abnormal physical examination findings. Such abnormalities will be closely monitored to their resolution.
DIARY CARD RECORDING
History of number of weekly angina episodes and nitroglycerin consumption will be obtained on Days -14. Once patient has signed informed consent form and been issued the diary card at Day -14, the number of weekly angina episodes and nitroglycerin consumption will be obtained during the study on days -7, 0, 14, 28 and 56.
Also recorded in the patient diary card will be any Adverse Events experienced by the patient, any concomitant medications taken as well as confirmation of each study drug dose received.
ETT
The ETT will be completed according to the Standard Bruce Protocol. The Standard Bruce Protocol is as follows (Appendix 1): Six 3-minute stages starting at 1.7 miles/hour and 10% gradient, increasing to 2.5 miles/hour and 12% gradient, 3.4 miles/hour and 14% gradient, 4.2 miles/hour and 16% gradient, 5.0 miles/hour and 18% gradient and 6 miles/hour and 20% gradient.
The study personnel will be instructed to refrain from communicating exercise times to the participating patients, for all examinations.
A supine standard 12 ?lead ECG will be obtained before each ETT, and standing ECGs will be monitored throughout the ETT.
VITAL SIGNS
Vital signs will be measured every 3 minutes during ETT and will include blood pressure and the heart rate. The HR will be recorded from the ECG recordings. Vital signs measurements will be obtained at days -14, -7, 0, 7, 14, 28, 29, 56 and 57. After the treatment start, any vital sign measurement determined by the investigator to be clinically significant will be noted as an AE on the appropriate CRF page(s). Whenever possible, the underlying diagnosis should be listed in lieu of abnormal vital signs measurements. Such abnormalities will be closely monitored to their resolution.
ELECTROCARDIOGRAM
The 12-lead ECGs will include a diagnostic impression as well as measurement of heart rate, PR interval, QRS interval, QT interval, and QTc interval. ECG will be performed at every visit.
SEATTLE ANGINA QUESTIONNAIRE
The Seattle Angina Questionnaire will be completed on days 0, 28 and 56. Patients will complete the questionnaire on a patient worksheet printed on NCR (No carbon required) paper. The top copy of the NCR paper will be part of the CRF, and the second copy will be left in the medical record.

Eligibility
Key inclusion criteria
1.Male or female aged 18 to 80 years.
2.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.
3.Evidence of coronary artery disease that consists of a well-documented medical history of myocardial infarction or significant coronary artery disease with non-invasive or angiographic confirmation.
4.Symptoms that support the diagnosis of chronic stable angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph changes.
5.Moderate (Class II or Class III according to Canadian Cardiovascular Society Angina Classification) angina pectoris
6.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.
7.Patient must be able to withdraw all anti-angina regimen (except short-acting nitroglycerin, beta-blockers or calcium channel blockers), that were used prior to this initial visit.
8.Patient must understand and be willing to comply with protocol visit schedule.
9.Patient must be able and willing to give informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Contraindication to perform treadmill Exercise Tolerance Test (ETT).

2.Presence of 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, to the investigator’s opinion, interfere with exercise electrocardiograph interpretation.

3.Clinically severe arrhythmias or atrioventricular conduction block greater than first degree.

4.Clinically severe co-morbidities, including hepatic or renal dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, current of cerebral hemorrhage, or seizure disorders that required anticonvulsant medication.

5.Recent history of congestive heart failure (occurrence within two weeks), 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.

6.Current bleeding diathesis, or current treatment with warfarin and/or on other oral anticoagulants, and inability to discontinue these medications.

7.Implanted pacemaker.

8.Aspirin and/or other platelet inhibitors including Clopidogrel, started less than 30 days prior to the signing of informed consent.

9.Pregnancy or lactation.

10.Inability to discontinue existing chronic nitrate regimen (e.g. long acting nitroglycerin) and other anti-angina medications except for beta-blockers or calcium channel blockers.

11.Participation in any other clinical trial or receipt of an investigational drug within 90 days prior to initial visit.

12.Previous participation in this study.

13.Substance abuse. Patients with a recent history (within the last 2 years) of alcoholism or known drug dependence.

14. Patient is a family member or relative of the study site staff.

15. Investigator’s opinion that the individual is not appropriate for the trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
12/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 1410 0
New Zealand
State/province [1] 1410 0

Funding & Sponsors
Funding source category [1] 4210 0
Commercial sector/Industry
Name [1] 4210 0
Tasly Pharmaceuticals, Inc.
Country [1] 4210 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
CNS Pty Ltd
Address
Level 3, 88 Jephson Street
Toowog, Brisbane Queensland 4066
Country
Australia
Secondary sponsor category [1] 3850 0
Commercial sector/Industry
Name [1] 3850 0
BELTAS
Address [1] 3850 0
PO Box 99728 Newmarket
Auckland 1149
Country [1] 3850 0
New Zealand

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29167 0
Address 29167 0
Country 29167 0
Phone 29167 0
Fax 29167 0
Email 29167 0
Contact person for public queries
Name 12324 0
CNS Project Manager
Address 12324 0
Level 4, 88 Jephson Street Toowong QLD 4066
Country 12324 0
Australia
Phone 12324 0
+61 7 3331 3933
Fax 12324 0
Email 12324 0
cns@clinical.net.au
Contact person for scientific queries
Name 3252 0
cns@clinical.net.au
Address 3252 0
Level 4, 88 Jephson Street Toowong QLD 4066
Country 3252 0
Australia
Phone 3252 0
+61 7 3331 3933
Fax 3252 0
Email 3252 0
cns@clinical.net.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.