Stable Angina PectorisPhase 3NCT02294942
Extended-Release RANCAD in the Patients With Stable Angina Pectoris
A Phase 3 study testing RANCAD in people with Stable Angina Pectoris, run by TSH Biopharm Corporation Limited at 6 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stable Angina Pectoris
- What is being tested?
- RANCAD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 6 sitesTaiwan
- Study dates
- Oct 2014to Dec 2016
- Phase
- Phase 3
- 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)
- Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT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
- 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
- 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
Show all 20Show fewer
- 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
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Far Eastern Memorial Hospital
New Taipei City, New Taipei city, 220
Mackay Memorial Hospital
Taipei, Taipei City, 104
Shin Kong WuHoSu Memorial Hospital
Taipei, 111
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan, 333
About this study
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.
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.
Read the 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.
- Conditions
- Stable Angina Pectoris
- Being tested
- RANCAD
- Keywords
- RNTA06, RANCAD
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RANCADDrug
Also called RNTA06
Extended-Release RANCAD
| Study group | Role | What they receive |
|---|---|---|
| RANCAD 500mg | Experimental | RANCAD 1 tab (500 mg) + Placebo 1 tab, twice daily. Receives: Drug: RANCAD |
| RANCAD 1000mg | Experimental | RANCAD 2 tabs (500 mg), twice daily Receives: Drug: RANCAD |
| Placebo | Active comparator | 2 tabs, twice daily Receives: Drug: RANCAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
ETT performing at last treatment visit (Week 12).
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.
Measured: Week 12 (not including screening & follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Angina PectorisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- TSH Biopharm Corporation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juey-Jen Hwang, M.D., Ph.D.,, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294942
- Sponsor's protocol ID
- TSHRN1201
- Status last verified
- Apr 2017
- First submitted
- 14 Nov 2014
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02294942
- Acronym / sponsor ID
- TSHRN1201
- Conditions
- Stable Angina Pectoris
- Keywords
- RNTA06, RANCAD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- TSH Biopharm Corporation LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Nov 2014 (estimated)
- 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.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RANCAD 500mg | Experimental | Drug: RANCADRANCAD 1 tab (500 mg) + Placebo 1 tab, twice daily. |
| RANCAD 1000mg | Experimental | Drug: RANCADRANCAD 2 tabs (500 mg), twice daily |
| Placebo | Active comparator | Drug: RANCAD2 tabs, twice daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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)
- 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
- 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
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 |
|---|---|---|
| RANCADAlso: RNTA06Extended-Release RANCAD | Drug | Placebo, RANCAD 1000mg, RANCAD 500mg |
Primary outcome
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.
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 28 Apr 2017.
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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.
Juey-Jen Hwang, M.D., Ph.D., principal investigator
National Taiwan University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RANCAD in people with Stable Angina Pectoris, run by TSH Biopharm Corporation Limited at 6 sites 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 6 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 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 at last treatment visit (Week 12). (time frame: Week 12 (not including screening & follow-up period)). 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 28 Apr 2017.