AnginaNCT03401502
A TSHRN1201 Sub-study-To Evaluate the Effects of add-on Ranolazine on Exercise Tolerance and Angina Frequency
A study testing Ranolazine in people with Angina, run by TSH Biopharm Corporation Limited at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Angina
- What is being tested?
- Ranolazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jun 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥ 20 years old.
- A minimum 3-month history of stable angina.
- 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)*;
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- 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.
- Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 5 days will be qualified for entering this study and performing 1st ETT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.
- 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.
- Willing and able to provide a written informed consent.
Who cannot join
- 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.
- Patients with family history of (or congenital) long QT syndrome.
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- Patients with congenital heart disease.
- Patients with uncorrected valvular heart disease.
- Patients with unstable angina, or MI, or coronary revascularization procedure ≤ 2 months prior enter this study.
- 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.
- 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.
- Use of any investigational product ≤ 4 weeks prior to screening.
- Patients with severe hepatic disease (e.g., liver cirrhosis).
- Patients with impaired renal function (defined as serum Cr >1.5 mg/dl).
- Patients with any condition or disease which is considered not suitable for this study by investigator.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, Zhongzheng Dist, 10048
About this study
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.
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.
- Conditions
- Angina
- Being tested
- Ranolazine, Placebos
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called RNTA
Oral, b.i.d
PlacebosDrug
Also called Placebo
Oral, b.i.d
| Study group | Role | What they receive |
|---|---|---|
| Treatment groups | Experimental | Ranolazine 1000 mg Receives: Drug: Ranolazine |
| Control group | Placebo comparator | Placebos Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
ETT performing duration
To compare the change from baseline of ETT performing duration between add-on Ranolazine and placebo
Measured: at trough (12 hours after dosing) at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start7 Jun 2018
- Primary completion30 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Treatment group:Ranolazine 1000 mg: * Control group: Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- TSH Biopharm Corporation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401502
- Sponsor's protocol ID
- TSHRN1701
- Status last verified
- Apr 2019
- First submitted
- 7 Jan 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03401502
- Acronym / sponsor ID
- TSHRN1701
- Conditions
- Angina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- TSH Biopharm Corporation LimitedIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- * Treatment group:Ranolazine 1000 mg: * Control group: Placebo
| Arm | Type | Receives |
|---|---|---|
| Treatment groups | Experimental | Drug: RanolazineRanolazine 1000 mg |
| Control group | Placebo comparator | Drug: PlacebosPlacebos |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients aged ≥ 20 years old.
- A minimum 3-month history of stable angina.
- Patients with diagnosis of coronary artery disease (CAD) via at least one of the following criteria:
- Previous MI history of patients has to be occurred and diagnosed at least 2 months prior entering this study.
- 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.
Key exclusion criteria (20 listed)
- Factors that might compromise ECG or ETT interpretation.
- Patients with family history of (or congenital) long QT syndrome.
- Patients with congenital heart disease.
- Patients with uncorrected valvular heart disease.
- Patients with unstable angina, or MI, or coronary revascularization procedure ≤ 2 months prior enter this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanolazineAlso: RNTAOral, b.i.d | Drug | Treatment groups |
| PlacebosAlso: PlaceboOral, b.i.d | Drug | Control group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ranolazine in people with Angina, run by TSH Biopharm Corporation Limited at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ETT performing duration (time frame: at trough (12 hours after dosing) at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.