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CompletedNCT03401502Updated Apr 10, 2019

A TSHRN1201 Sub-study-To Evaluate the Effects of add-on Ranolazine on Exercise Tolerance and Angina Frequency

An interventional study of Ranolazine and Placebos in Angina, sponsored by TSH Biopharm Corporation Limited. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by TSH Biopharm Corporation Limited · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

This is a double-blind, randomized, placebo-controlled, and parallel study. The study is comprised of three main phases: a single-blind placebo run-in qualifying phase lasting about 14 days, a double-blind treatment phase of 12 weeks, and a 2-week follow-up phase. Approximately 18 patients will be enrolled and randomly assigned to receive placebo or 1,000 mg of extended-release Ranolazine twice-daily for 12 weeks to reach 14 evaluable patients at the end of the study.

Read the detailed description

This is a double-blind, randomized, placebo-controlled, and parallel study. The study is comprised of three main phases: a single-blind placebo run-in qualifying phase lasting about 14 days, a double-blind treatment phase of 12 weeks, and a 2-week follow-up phase. Approximately 18 patients will be enrolled and randomly assigned to receive placebo or 1,000 mg of extended-release Ranolazine twice-daily for 12 weeks to reach 14 evaluable patients at the end of the study.

Patients with chronic angina pectoris will be screened for eligibility after providing informed consent. Patients present with the symptoms of stable angina after withdrawn from other antianginal agents and given the required background therapy for at least 5 days will be qualified for entering this study and performing 1st ETT qualifying test.

02

Conditions studied

  • Angina

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03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
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) via at least one of the following criteria:

    • Angiographic evidence of ≥ 50% stenosis of ≥ 1 major coronary artery;
    • CT angiographic evidence of ≥ 50% stenosis of ≥ 1 major coronary artery;
    • History of previous myocardial infarction (MI)*;

      *Previous MI history of patients has to be occurred and diagnosed at least 2 months prior entering this study.

    • A stress-induced reversible perfusion defect identified by radionuclide or echocardiographic imaging.
  4. Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 5 days will be qualified for entering this study and performing 1st ETT qualifying test.
  5. Patients developed exercise-induced ECG ischemia during two qualifying exercise treadmill tests. The difference between twotests should be ≤ 20% of the longer test or ≤ 1 minute.
  6. Willing and able to provide a written informed consent.

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Treatment groups

    Ranolazine 1000 mg

    Drug: Ranolazine

  • Placebo comparator
    Control group

    Placebos

    Drug: Placebos

Interventions

  • DrugRanolazine

    Oral, b.i.d

    Also known as: RNTA

  • DrugPlacebos

    Oral, b.i.d

    Also known as: Placebo

05

What researchers measure

Primary outcomes

  1. ETT performing duration

    To compare the change from baseline of ETT performing duration between add-on Ranolazine and placebo

    Time frame: at trough (12 hours after dosing) at Week 12

06

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, Zhongzheng Dist 10048, Taiwan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03401502
Lead sponsor
TSH Biopharm Corporation Limited
Responsible party
Sponsor
First posted
Jan 17, 2018
Start date
Jun 7, 2018
Primary completion
Mar 30, 2019
Completion
Mar 31, 2019
Last update
Apr 10, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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