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A Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Cilostazol in Subjects With Vasospastic Angina

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Pletaal(Cilostazol) in Subjects With Vasospastic Angina

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02087007
Acronym
STELLA
Enrollment
100
Registered
2014-03-14
Start date
2013-11-30
Completion date
2015-07-31
Last updated
2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasospastic Angina

Keywords

Treatment for vasospastic angina

Brief 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 KFDA. Each subject will participate around 7 weeks, which include the 2 weeks Amlodipine run-in period, 4 weeks double blind period and 1 week safety follow up period

Detailed description

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel group, Therapeutic confirmatory Study. The subject who has at least one episode of chest pain weekly and at least two episodes of chest pain during last week despite Amlodipine 5mg qd taking during 2 weeks will have treatment of Pletaal(Cilostazol) or Placebo for 4 weeks. Pletaal(Cilostazol) is taken 100mg oral tablets bid during 2 weeks after dosing of Pletaal(Cilostazol) 50mg oral tablets bid during 2 weeks. Placebo of Pletaal(Cilostazol) is used as the control medication.

Interventions

DRUGCilostazol

100mg oral tablets bid during 2 weeks after dosing of 50mg oral tablets bid during 2 weeks

DRUGplacebo

100mg oral placebo tablets bid during 2 weeks after dosing of 50mg oral placebo tablets bid during 2 weeks

Sponsors

Korea Otsuka Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study : 1. Male or female 20 or over the age of 20 and under the age of 80. 2. Patients showing angina attack even while resting during the screening, diagnosed with vasospastic angina within the previous 3 months by meeting at least one of the 3 definitions, and accompanying insignificant (stenosis rate \<50%) coronary artery disease documented by coronary angiography within the last 3 months \[temporary antispastic agents (monotherapies or a combination of Verapamil and Nitroglycerin, anticoagulants) for coronary angiography are allowed\] * Chest pain accompanied by at least 2 temporary, closely located ST elevations or depressions of 0.1mV or greater in the absence of ergonovine provoked coronary angiography. * Positive Intracoronary (IC) or Intravenous (IV) Ergonovine provocation test; ischemic ECG change accompanied by chest pain and spasm reducing the coronary diameter by 90% or more (at least 2 temporary, closely located ST elevations or depressions of 0.1mV or greater on 12-lead ECG) 3. Patients who reported at least 1 episode of chest pain in a week during amlodipine run-in period and at least 2 episodes in the final week. 4. Women who had been menopausal or sterile for at least 1 year, or women of childbearing potential 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) 5. 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. Subjects presenting with any of the following will not be included in the study: 1. Subjects who used Cilostazol within 3 months before the screening visit 2. Subjects who used antiplatelet drugs, including Aspirin, Clopidogrel, Ticlopidine and Sarpogrelate, or PDE3 inhibitors of the same class as Cilostazol, such as Amrinone, Milrinone and Enoximone, after the initiation of the amlodipine run-in period 3. Subjects who used oral anticoagulants, such as warfarin, within 1 months prior to the screening visit 4. Subjects who used any of the following drugs within 1 week prior to the screening visit * CCBs apart from amlodipine * Beta-blockers or alpha-blockers * Oral nitrate, excluding nitroglycerin sublingual tablet, Nicorandil * Vitamin E preparations * Estrogens 5. History of myocardial infarction or with myocardial infarction mediated by vasospastic angina at the time of screening 6. History of a life-threatening vasospastic event (e.g., ventricular tachycardia, atrial fibrillation or syncope) 7. History of stroke, intracranial hemorrhage or transient ischemic attack (TIA) 8. Hemorrhage (hemophilia, capillary fragility, upper gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.) or such predisposition (active peptic ulcer, hemorrhage suspected at Cilostazol administration for surgical wound within the last 3 months, proliferative diabetic retinopathy) 9. History of hypersensitivity to the ingredients of Cilostazol, amlodipine, dihydropyridines such as nitroglycerine, and nitrates 10. Severe aortic stenosis 11. History of shock 12. Hypotension with systolic pressure of below 90mmHg at screening 13. Severe anemia with hemoglobin 6.5g/dl or below at screening 14. History of glaucoma 15. ST change abnormality not interpretable on ECG at screening 16. Congestive heart failure with left ventricular ejection fraction \<40% on echocardiography at screening or within the last 3 months 17. Atrial fibrillation or beyond moderate valvular heart disease 18. Left main coronary spasm suspected or confirmed by coronary angiography or ergonovine provoked coronary angiography 19. History of coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) 20. Heart rate \>100 bpm at screening via vital sign: tachycardia 21. Uncontrolled hypertension with systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg at screening 22. Creatinine level ≥ 1.5 mg/dL at screening 23. AST or ALT \> x3 ULN(Upper Limit of Normal) at screening 24. Platelet count \< 100,000mm3 at screening 25. QT prolongation of QTcB \> 450 msec in male and QTcB\>470 msec in female subjects at screening 26. Women of childbearing potential with positive pregnancy test at screening 27. Women who did not agree to practice a contraceptive measure, pregnant or lactating women 28. Drug compliance of less than 80% during 2-week amlodipine run-in period 29. Subjects otherwise judged by the investigator to be inappropriate for inclusion in the trial 30. Subjects who used another investigational products within 2 months prior to the randomization

Design outcomes

Primary

MeasureTime frameDescription
Chest Pain FrequencyBaseline and Week 4Change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing

Secondary

MeasureTime frameDescription
Percent change of the chest pain frequencyBaseline and Week 4Percent change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing
Proportion of subjects without chest pain4 weeksProportion of subjects without chest pain on the final a week after IP dosing
total chest pain intensityBaseline and Week 4Change of the total pain intensity on the final a week after IP dosing from a week before IP dosing
average pain intensity(the total pain intensity/the number of pain)Baseline and Week 4Change of the average pain intensity(the total pain intensity/the number of pain) on the final a week after IP dosing from a week before IP dosing
total nitroglycerin sublingual consumptionBaseline and Week 4Change of the total nitroglycerin sublingual consumption of the final a week after IP dosing from a week before IP dosing

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026