Extended-Release RANCAD in the Patients With Stable Angina Pectoris

April 26, 2017 updated by: TSH Biopharm Corporation Limited

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei city, Taiwan, 220
        • Far Eastern Memorial Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 111
        • Shin Kong WuHoSu Memorial Hospital
      • Taipei City, Taiwan, 104
        • Mackay Memorial Hospital
      • Taoyuan, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ETT performing at last treatment visit (Week 12).
Time Frame: 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.
Week 12 (not including screening & follow-up period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TSH Biopharm Corporation Limited

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSHRN1201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stable Angina Pectoris

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe