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Extended-Release RANCAD in the Patients With Stable Angina Pectoris

Sponsor
TSH Biopharm Corporation Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT02294942
Collaborator
(none)
75
Enrollment
6
Locations
3
Arms
26
Duration (Months)
12.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: RANCAD 500mg

RANCAD 1 tab (500 mg) + Placebo 1 tab, twice daily.

Drug: RANCAD
Extended-Release RANCAD
Other Names:
  • RNTA06

    		•
    Experimental: RANCAD 1000mg

    RANCAD 2 tabs (500 mg), twice daily

    Drug: RANCAD
    Extended-Release RANCAD
    Other Names:
  • RNTA06

    		•
    Active Comparator: Placebo

    2 tabs, twice daily

    Drug: RANCAD
    Extended-Release RANCAD
    Other Names:
  • RNTA06

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ETT performing at last treatment visit (Week 12). [Week 12 (not including screening & follow-up period)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. 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
    1. 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

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

    2. Patients with congenital heart disease

    3. Patients with uncorrected valvular heart disease

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

    5. 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.

    1. 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

    1. Use of any investigational product ≤ 4 weeks prior to screening

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

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

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Far Eastern Memorial Hospital New Taipei city Taiwan 220
    2 Mackay Memorial Hospital Taipei City Taiwan 104
    3 Shin Kong WuHoSu Memorial Hospital Taipei Taiwan 111
    4 National Taiwan University Hospital Taipei Taiwan
    5 Taipei Veterans General Hospital Taipei Taiwan
    6 Linkou Chang Gung Memorial Hospital Taoyuan Taiwan 333

    Sponsors and Collaborators

    • TSH Biopharm Corporation Limited

    Investigators

    • Principal Investigator: Juey-Jen Hwang, M.D., Ph.D.,, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TSH Biopharm Corporation Limited
    ClinicalTrials.gov Identifier:
    NCT02294942
    Other Study ID Numbers:
    • TSHRN1201
    First Posted:
    Nov 19, 2014
    Last Update Posted:
    Apr 28, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by TSH Biopharm Corporation Limited
    RNTA06
    RANCAD
    Additional relevant MeSH terms:
    Angina Pectoris
    Angina, Stable

    Study Results

    No Results Posted as of Apr 28, 2017