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

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ClinicalTrials.gov Identifier: NCT03401502
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
TSH Biopharm Corporation Limited

Brief 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.

Condition or disease Intervention/treatment Phase
Angina Drug: Ranolazine Drug: Placebos Not Applicable

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 Patients present with the symptoms of stable angina after withdrawn from other antianginal agents and given the required background therapy for at least 5 days will be qualified for entering this study and performing 1st ETT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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Treatment group:Ranolazine 1000 mg:
  • Control group: Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: A TSHRN1201 Sub-study-To Evaluate the Effects of add-on Ranolazine on Exercise Tolerance and Angina Frequency in Patients With Stable Angina Pectoris.
Actual Study Start Date : June 7, 2018
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
Drug Information available for: Ranolazine

Arm Intervention/treatment
Experimental: Treatment groups
Ranolazine 1000 mg
Drug: Ranolazine
Oral, b.i.d
Other Name: RNTA

Placebo Comparator: Control group
Placebos
Drug: Placebos
Oral, b.i.d
Other Name: Placebo




Primary Outcome Measures :
  1. ETT performing duration [ Time Frame: at trough (12 hours after dosing) at Week 12 ]
    To compare the change from baseline of ETT performing duration between add-on Ranolazine and placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401502


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng Dist, Taiwan, 10048
Sponsors and Collaborators
TSH Biopharm Corporation Limited

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Responsible Party: TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier: NCT03401502     History of Changes
Other Study ID Numbers: TSHRN1701
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action