Vasospastic AnginaPhase 3STELLA_ExtNCT02094469
Safety and Efficacy Study of Cilostazol to Treat Vasospastic Angina
A Phase 3 study testing Cilostazol in people with Vasospastic Angina, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This study will be conducted in accordance with the local regulation of New Drug Application. Overall duration of this trial will be 3 years after approval of MFDS. Each subject will participate around 26 weeks, which include the 24 weeks treatment period and 2 weeks safety follow up period. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Vasospastic Angina
- What is being tested?
- Cilostazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Jan 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 20 to 80 years, and subjects whose age at the time of enrollment was 80 in 021-KOA-1301i clinical trial and is 81 in this clinical trial
- Subjects who completed 021-KOA-1301i clinical trial
- Women of childbearing potential with negative pregnancy test at enrollment and who agree to practice a contraceptive measure throughout the clinical trial (e.g., hormonal contraceptives, intrauterine devices, condom + spermicidal agents, diaphragm + spermicidal agents, and partner's infertility)
- Subjects who signed a written agreement indicating that they were given full explanations of the clinical trial and are willing to participate in the clinical trial
Who cannot join
- Subjects who fell under one of the exclusion criteria at the time of enrollment for 021-KOA-1301i
- Subjects who reported any of the following events, which fall under the exclusion criteria for KOA-1301i, between the initiation of 021-KOA-1301i participation and enrollment visit for 021-KOA-1302i
- Myocardial infarction or myocardial infarction induced by vasospastic angina
- Life-threatening vasospastic episodes (e.g., ventricular tachycardia, ventricular fibrillation, or syncope)
- Stroke, intracranial hemorrhage, or transient ischemic attack (TIA)
- Hemorrhage (hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.)
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- Subjects who are currently using any of the medications contraindicated in 021-KOA-1301i (excluding the investigational product of 021-KOA-1301i) at baseline
- Subjects who meet the following criteria for baseline laboratory findings
- severe anemia with hemoglobin ≤6.5 g/dl at baseline
- Creatinine level ≥ 1.5 mg/dL at baseline
- AST or ALT >3x ULN at baseline
- Platelet count < 100,000mm3 at baseline
- Pulse rate exceeding 100 bpm when measured for vital signs at baseline: Tachycardia
- Hypotension with systolic pressure < 90mmHg at baseline
- Uncontrolled hypertension defined as systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg at baseline
- QT prolongation defined as QTcB > 450 msec for men and QTcB > 470 msec for women at baseline
- Women of childbearing potential with positive pregnancy test at baseline
- Women who do not agree to practice a contraceptive measure, or are pregnant or lactating
- Subjects who are not expected to have the potential to benefit from additional administration of Cilostazol, according to the investigator's judgment
- Subjects otherwise judged by the investigator to be inappropriate for inclusion in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, One Group, Open-label Study to Evaluate the Safety and Efficacy of Pletaal(Cilostazol) as BID for up to 24 Weeks Exposure in Subjects With Vasospastic Angina (STELLA Extension)
This study will be conducted in accordance with the local regulation of New Drug Application. Overall duration of this trial will be 3 years after approval of MFDS.
Each subject will participate around 26 weeks, which include the 24 weeks treatment period and 2 weeks safety follow up period. Withdrawn subjects due to efficacy after 4 weeks treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn subjects with other reason also have 2 weeks follow up period.
Read the detailed description
A Multicenter, One group, Open-label Study. Cilostazol will be treated for additional 24 weeks to the subject who had completed 021-KOA-1301i study. PletaalÒ(Cilostazol) is taken 100mg oral tablets bid during 2 3weeks after dosing of PletaalÒ(Cilostazol) 50mg oral tablets bid during 1 week. The dose can be adjusted by investigator's discretion during the study and the detailed method is described in the Protocol. Subject who has 2 or more chest pain at 4th week will be withdrawn from the study (But, subjects who show 50% or more of chest pain decrease compared to 1st week would not be withdrawn.). Subjects who participated in this trial will have 2 weeks follow-up after study completion.
- Conditions
- Vasospastic Angina
- Being tested
- Cilostazol
- Keywords
- Treatment for vasospastic angina
- Medical subject headings
- Angina Pectoris, Variant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
Also called Pletaal
Oral, Bid, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol | Other | Cilostazol 50mg and 100mg Receives: Drug: Cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period
Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period
Measured: 24 weeks
Secondary outcomes (3)
secondary 1
Change/rate of change in the frequency of chest pain in the final 1week/2 weeks after the 24-week treatment period compared to those in the final 1 week/2weeks of Amlodipine run-in period in 021-KOA-1301i
Measured: 24 week
secondary 2
Mean change in the intensity of chest pain in the final 1 week/2 weeks after the 24-week treatment period compared to that in the final 1 week/2weeks of Amlodipine run-in period in 021-KOA-1301i
Measured: 4 weeks
secondary 3
4-week cumulative rate of subjects withdrawn due to lack of efficacy
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasospastic 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junghong Kim, MD, Principal investigator, Yangsan Busan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094469
- Sponsor's protocol ID
- 021-KOA-1302i
- Acronym
- STELLA_Ext
- Status last verified
- Jan 2016
- First submitted
- 20 Mar 2014
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, One Group, Open-label Study to Evaluate the Safety and Efficacy of Pletaal(Cilostazol) as BID for up to 24 Weeks Exposure in Subjects With Vasospastic Angina (STELLA Extension)
- ClinicalTrials.gov ID
- NCT02094469
- Acronym / sponsor ID
- STELLA_Ext / 021-KOA-1302i
- Conditions
- Vasospastic Angina
- Keywords
- Treatment for vasospastic angina
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Mar 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.
This study will be conducted in accordance with the local regulation of New Drug Application. Overall duration of this trial will be 3 years after approval of MFDS.
Each subject will participate around 26 weeks, which include the 24 weeks treatment period and 2 weeks safety follow up period. Withdrawn subjects due to efficacy after 4 weeks treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn subjects with other reason also have 2 weeks follow up period.
Detailed description
A Multicenter, One group, Open-label Study. Cilostazol will be treated for additional 24 weeks to the subject who had completed 021-KOA-1301i study. PletaalÒ(Cilostazol) is taken 100mg oral tablets bid during 2 3weeks after dosing of PletaalÒ(Cilostazol) 50mg oral tablets bid during 1 week. The dose can be adjusted by investigator's discretion during the study and the detailed method is described in the Protocol. Subject who has 2 or more chest pain at 4th week will be withdrawn from the study (But, subjects who show 50% or more of chest pain decrease compared to 1st week would not be withdrawn.). Subjects who participated in this trial will have 2 weeks follow-up after study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cilostazol | Other | Drug: CilostazolCilostazol 50mg and 100mg |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects aged 20 to 80 years, and subjects whose age at the time of enrollment was 80 in 021-KOA-1301i clinical trial and is 81 in this clinical trial
- Subjects who completed 021-KOA-1301i clinical trial
- Women of childbearing potential with negative pregnancy test at enrollment and who agree to practice a contraceptive measure throughout the clinical trial (e.g., hormonal contraceptives, intrauterine devices, condom + spermicidal agents, diaphragm + spermicidal agents, and partner's infertility)
- Subjects who signed a written agreement indicating that they were given full explanations of the clinical trial and are willing to participate in the clinical trial
Key exclusion criteria (20 listed)
- Subjects who fell under one of the exclusion criteria at the time of enrollment for 021-KOA-1301i
- Subjects who reported any of the following events, which fall under the exclusion criteria for KOA-1301i, between the initiation of 021-KOA-1301i participation and enrollment visit for 021-KOA-1302i
- Subjects who are currently using any of the medications contraindicated in 021-KOA-1301i (excluding the investigational product of 021-KOA-1301i) at baseline
- Subjects who meet the following criteria for baseline laboratory findings
- Pulse rate exceeding 100 bpm when measured for vital signs at baseline: Tachycardia
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 |
|---|---|---|
| CilostazolAlso: PletaalOral, Bid, 24 weeks | Drug | Cilostazol |
Primary outcome
Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period
Time frame: 24 weeks
Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period
3 secondary outcomes
secondary 1
Time frame: 24 week
secondary 2
Time frame: 4 weeks
secondary 3
Time frame: 4 weeks
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 29 Jan 2016.
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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.
Junghong Kim, MD principal investigator
Yangsan Busan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cilostazol in people with Vasospastic Angina, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 4 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 29 Jan 2016. 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 South Korea. 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?
Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period (time frame: 24 weeks). 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 29 Jan 2016.