Status:
COMPLETED
Extended-Release RANCAD in the Patients With Stable Angina Pectoris
Lead Sponsor:
TSH Biopharm Corporation Limited
Conditions:
Stable Angina Pectoris
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
A double-blind, randomized, placebo-controlled, parallel study to evaluate the effects of add-on RANCAD on exercise tolerance and angina frequency in patients with stable angina pectoris.
Detailed Description
Primary objective is to to determine the effects of add-on RANCAD on exercise treadmill test (ETT) duration at trough plasma level of RANCAD level after 12-weeks therapy.
Eligibility Criteria
Inclusion
- Male or female patients aged ≥ 20 years old
- A minimum 3-month history of stable angina
- Patients with diagnosis of coronary artery disease (CAD)
- Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT qualifying test
- Patients developed exercise-induced ECG ischemiai during two qualifying exercise treadmill testsii. The difference between twoiii tests should be ≤ 20% of the longer test or ≤ 1 minute i. Exercise-induced ECG ischemia is defined as the new development of horizontal or down-sloping ST-segment depression of ≥1mm at 60-80ms after the J point; if patients with baseline ST depression at rest (\<1mm), qualifying ST segment depression is defined as additional ST depression of at least 1 mm below the resting value ii. Exercise treadmill test (ETT) will be performed by Modified Bruce Protocol. iii. Two qualifying tests will be conducted 1 week apart, a 3rd ETT test will be performed ≤ 3 days when differences between previous two qualifying ETTs \>20% of the longer test or \>1 minute
- Willing and able to provide a written informed consent
Exclusion
- Factors that might compromise ECG or ETT interpretation
- Patients with resting ST-segment depression ≥ 1mm in any lead
- Left bundle-branch block
- Patients implanted with pacemaker
- Patients under Digitalis therapy
- Patients with family history of (or congenital) long QT syndrome
- Patients with congenital heart disease
- Patients with uncorrected valvular heart disease
- Patients with unstable angina, or MI, or coronary revascularization procedure ≤ 2 months prior enter this study
- Female who is pregnant/lactating or planning to be pregnant, or female of childbearing potential\* who is not using medically recognized method of contraception
- \*Other than those who have been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal.
- Patients are under any one of the following conditions:
- New York Heart Association (NYHA) Class III or Class IV congestive heart failure (CHF)
- QTc \> 450 msec at screening
- Active myocarditis, pericarditis, hypertrophic cardiomyopathy
- Uncontrolled hypertension (defined as SBP \> 180 mmHg) Voltage criteria for left ventricular hypertrophy in the absence of repolarization abnormalities will not be exclusion criteria
- Use of any investigational product ≤ 4 weeks prior to screening
- Patients with severe hepatic disease (e.g., liver cirrhosis)
- Patients with impaired renal function (defined as serum Cr \>1.5 mg/dl)
- Patients with any condition or disease which is considered not suitable for this study by investigator
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02294942
Start Date
October 1 2014
End Date
December 1 2016
Last Update
April 28 2017
Active Locations (6)
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1
Far Eastern Memorial Hospital
New Taipei City, New Taipei city, Taiwan, 220
2
Mackay Memorial Hospital
Taipei, Taipei City, Taiwan, 104
3
Shin Kong WuHoSu Memorial Hospital
Taipei, Taiwan, 111
4
National Taiwan University Hospital
Taipei, Taiwan