Evaluate the Efficacy and Safety of Pletaal (Cilostazol) in Subjects With Vasospastic Angina (STELLA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01444885
First received: September 27, 2011
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

The objective of this study is to investigate the efficacy and safety of Pletaal (Cilostazol) in comparison with placebo for 4 weeks in vasospastic angina patients who have an insufficient response to Amlodipine (Calcium channel blocker).


Condition Intervention Phase
Variant Angina
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of PletaalÒ(Cilostazol) in Subjects With Vasospastic Angina (STELLA)

Resource links provided by NLM:


Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

Primary Outcome Measures:
  • Percent change of the chest pain frequency [ Time Frame: A week before IP dosing and the final a week after IP dosing (average 6weeks) ] [ Designated as safety issue: Yes ]

    Collect the chest pain frequency data related with vasospastic angina episodes by subject diaries.

    Descriptive statistics (N, mean, standard deviation, minimum, median and maximum) will be presented by treatment group. ANCOVA will be performed between the treatment groups using the baseline (a week before IP dosing) as covariate.



Secondary Outcome Measures:
  • The chest pain frequency, the pain intensity, nitroglycerin consumption of the final a week after IP dosing from a week before IP dosing [ Time Frame: A week before IP dosing and the final a week after IP dosing (average 6weeks) ] [ Designated as safety issue: Yes ]
    Descriptive statistics (N, mean, standard deviation, minimum, median and maximum) will be presented by treatment group. ANCOVA will be performed between the treatment groups using the baseline (a week before IP dosing) as covariate. The subject who has no chest pain will be regarded as the total pain intensity and the average pain intensity are '0'. The subject who has taken no nitroglycerin will be regarded as taking '0' tablet.


Enrollment: 50
Study Start Date: October 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cilostazol
To investigate the efficacy and safety of Pletaal(Cilostazol) in comparison with placebo for 4 weeks in vasospastic angina patients who have an insufficient response to Amlodipine (Calcium channel blocker).
Drug: Placebo
2 weeks treatment of Cilostazol 100mg, or placebo oral tablets bid after 2 weeks treatment of Cilostazol 50mg, or placebo oral tablets bid (Total 4 weeks)
Other Names:
  • Amlodipine
  • Nitroglycerin

Detailed Description:

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel group, Therapeutic exploratory Study.

The subject who has at least an episode of chest pain weekly despite Amlodipine 5mg once a day (qd) taking during 2 weeks will have treatment of Pletaal (Cilostazol) or Placebo for 4 weeks. Pletaal (Cilostazol) is taken 100mg oral tablets two times a day (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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female over the age of 20 and under the age of 80
  2. Diagnosis of vasospastic angina
  3. At least one episode of chest pain weekly during the Amlodipine run in period for 2 weeks

Exclusion Criteria:

  1. Currently taking or has taken Cilostazol within the last 3 month before the screening.
  2. Taking oral antiplatelet agents such as Aspirin, Clopidogrel after Amlodipine run-in period.
  3. Oral anticoagulants such as Warfarin within the last a month before the screening.
  4. Currently taking any of the following medications or has taken any of the following medications within the last a week before the screening:

    • Other Calcium channel blockers than Amlodipine
    • Beta-blocker, or Alpha-blocker
    • Oral Nitrate, Nicorandil, except sublingual Nitroglycerin as required(PRN)
    • Vitamin E preparations
    • Estrogens
  5. History of Myocardial infarction or Myocardial infarction by vasospastic angina at screening
  6. History of life threatening vasospastic events such as ventricular tachycardia , ventricular fibrillation, or syncope
  7. History of stroke, intracranial hemorrhage, or Transient Ischemic Attack(TIA)
  8. Hemorrhage (hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal hemorrhage, urinary hemorrhage, hemoptysis, vitreous hemorrhage, etc.) or such tendency (active peptic ulcer, hemorrhagic stroke within past 6 months, a case hemorrhage is suspected by wound for surgery within 3 months, proliferative diabetic retinopathy and uncontrolled hypertension)
  9. History of clinically significant hypersensitivity to the substances of Cilostazol, Amlodipine, Nitroglycerin or dihydropyridine
  10. Patients with severe aortic valvular stenosis
  11. History of shock
  12. Hypotension of diastolic pressure < 90 mmHg at screening
  13. History of clinically significant hypersensitivity to the substances of Nitrates
  14. Patients with severe anemia of Hemoglobin ≤ 6.5 g/dl at screening
  15. History of glaucoma
  16. Electrocardiogram(ECG) abnormality precluding interpretation of ST change at screening
  17. Congestive heart failure with less than 40% of left ventricular ejection fraction within the last 3 month before the screening or screening period
  18. Atrial fibrillation or valvular heart disease, more than moderate severity
  19. Suspected or identified spasm of left main coronary artery, result of coronary angiography or coronary angiography in the ergonovine induced coronary spasm provocation test
  20. History of Coronary artery bypass graft(CABG) or percutaneous coronary intervention(PCI)
  21. Tachycardia; Heart rate > 100 bpm, at Screening
  22. Uncontrolled hypertension, defined as ≥ 160 mmHg systolic or ≥ 100 mmHg diastolic at Screening
  23. Creatinine ≥ 1.5 mg/dL at screening
  24. Aspartate transaminase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal (ULN) at screening
  25. Platelet < 100,000 mm3 at screening
  26. QT prolongation defined as baseline QTc > 450 msec for males or > 470 msec for females at Screening.
  27. Women who have the possible of pregnancy, or positive urine or blood pregnancy test at screening
  28. Women who are not using a reliable method of birth control, who are pregnant, or who are breast-feeding
  29. Drug compliance of Amlodipine < 80% during the Amlodipine run in period for 2 weeks
  30. Otherwise judged by the investigator to be inappropriate for inclusion in the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444885

Locations
Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
ChungNam Univ. Hospital
DaeJeon, Korea, Republic of
Gangneung Asan Hospital
Gangneung, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Gyongsang National University Hospital
Jinjoo, Korea, Republic of
Pusan National University Yansan Hospital
Pusan, Korea, Republic of
Dong-A University Hospital
Pusan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co.,Ltd.
Investigators
Principal Investigator: June Hong Kim, MD Pusan National University Yansan Hospital
  More Information

No publications provided

Responsible Party: Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01444885     History of Changes
Other Study ID Numbers: STELLA
Study First Received: September 27, 2011
Last Updated: July 13, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:
Variant angina
Cilostazol

Additional relevant MeSH terms:
Angina Pectoris
Angina Pectoris, Variant
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Angina, Unstable
Cilostazol
Nitroglycerin
Amlodipine
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hematologic Agents

ClinicalTrials.gov processed this record on August 28, 2014