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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02294942
Other study ID # TSHRN1201
Secondary ID
Status Completed
Phase Phase 3
First received November 14, 2014
Last updated April 26, 2017
Start date October 2014
Est. completion date December 2016

Study information

Verified date April 2017
Source TSH Biopharm Corporation Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

1. Male or female patients aged = 20 years old

2. A minimum 3-month history of stable angina

3. Patients with diagnosis of coronary artery disease (CAD)

4. Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT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

5. 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

6. Willing and able to provide a written informed consent

Exclusion Criteria:

1. 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

2. Patients with family history of (or congenital) long QT syndrome

3. Patients with congenital heart disease

4. Patients with uncorrected valvular heart disease

5. Patients with unstable angina, or MI, or coronary revascularization procedure = 2 months prior enter this study

6. 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.

7. 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

8. Use of any investigational product = 4 weeks prior to screening

9. Patients with severe hepatic disease (e.g., liver cirrhosis)

10. Patients with impaired renal function (defined as serum Cr >1.5 mg/dl)

11. Patients with any condition or disease which is considered not suitable for this study by investigator

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RANCAD
Extended-Release RANCAD

Locations

Country Name City State
Taiwan Far Eastern Memorial Hospital New Taipei city
Taiwan National Taiwan University Hospital Taipei
Taiwan Shin Kong WuHoSu Memorial Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Mackay Memorial Hospital Taipei City
Taiwan Linkou Chang Gung Memorial Hospital Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
TSH Biopharm Corporation Limited

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary ETT performing at last treatment visit (Week 12). To compare the change from baseline of ETT performing duration between add-on RANCAD and placebo at trough (12 hours after dosing) at Week 12. Week 12 (not including screening & follow-up period)
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