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

NCT01444885 | Completed Phase 2

• 1 other identifier: STELLA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 10

Brief Summary

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).

Conditions

Variant Angina

Keywords

Variant angina; Cilostazol

Outcome Measures

Primary Outcomes (1)

• Percent change of the chest pain frequency

  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.

  A week before IP dosing and the final a week after IP dosing (average 6weeks)

Secondary Outcomes (1)

• The chest pain frequency, the pain intensity, nitroglycerin consumption of the final a week after IP dosing from a week before IP dosing

  A week before IP dosing and the final a week after IP dosing (average 6weeks)

Study Arms (1)

Cilostazol

EXPERIMENTAL

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

Interventions

Placebo DRUG

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)

Also known as: Amlodipine, Nitroglycerin

Cilostazol

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Currently taking or has taken Cilostazol within the last 3 month before the screening.
• Taking oral antiplatelet agents such as Aspirin, Clopidogrel after Amlodipine run-in period.
• Oral anticoagulants such as Warfarin within the last a month before the screening.
• 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
• History of Myocardial infarction or Myocardial infarction by vasospastic angina at screening
• History of life threatening vasospastic events such as ventricular tachycardia , ventricular fibrillation, or syncope
• History of stroke, intracranial hemorrhage, or Transient Ischemic Attack(TIA)
• 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)
• History of clinically significant hypersensitivity to the substances of Cilostazol, Amlodipine, Nitroglycerin or dihydropyridine
• Patients with severe aortic valvular stenosis

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (10)

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

ChungNam Univ. Hospital

Daejeon, South Korea

Location

Gangneung Asan Hospital

Gangneung, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Gyongsang National University Hospital

Jinjoo, South Korea

Location

Dong-A University Hospital

Pusan, South Korea

Location

Pusan National University Yansan Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Related Publications (1)

• Shin ES, Lee JH, Yoo SY, Park Y, Hong YJ, Kim MH, Lee JY, Nam CW, Tahk SJ, Kim JS, Jeong YH, Lee CW, Shin HK, Kim JH. A randomised, multicentre, double blind, placebo controlled trial to evaluate the efficacy and safety of cilostazol in patients with vasospastic angina. Heart. 2014 Oct;100(19):1531-6. doi: 10.1136/heartjnl-2014-305986. Epub 2014 Jun 16.

  PMID: 24934484 DERIVED

MeSH Terms

Conditions

Angina Pectoris, Variant

Interventions

Amlodipine; Nitroglycerin

Condition Hierarchy (Ancestors)

Angina, Unstable; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitro Compounds; Organic Chemicals

Study Officials

• June Hong Kim, MD

  Pusan National University Yansan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: October 3, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 16, 2012

Record last verified: 2012-07

Locations

KR (10)