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

NCT02087007 | Completed Phase 3 DMC

• 1 other identifier: 021-KOA-1301i
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Vasospastic Angina

Keywords

Treatment for vasospastic angina

Outcome Measures

Primary Outcomes (1)

• Chest Pain Frequency

  Change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing

  Baseline and Week 4

Secondary Outcomes (5)

• Percent change of the chest pain frequency

  Baseline and Week 4

• Proportion of subjects without chest pain

  4 weeks

• total chest pain intensity

  Baseline and Week 4

• average pain intensity(the total pain intensity/the number of pain)

  Baseline and Week 4

• total nitroglycerin sublingual consumption

  Baseline and Week 4

Study Arms (2)

group 1

EXPERIMENTAL

Cilostazol 50mg, Cilostzaol 100mg

Drug: Cilostazol

group 2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

Cilostazol DRUG

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

group 1

placebo DRUG

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

group 2

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 20 or over the age of 20 and under the age of 80.
• 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)
• 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.
• 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)
• 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:
• Subjects who used Cilostazol within 3 months before the screening visit
• 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
• Subjects who used oral anticoagulants, such as warfarin, within 1 months prior to the screening visit
• 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

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Yangsan Busan University Hospital

Busan, 626-770, South Korea

Location

MeSH Terms

Conditions

Angina Pectoris, Variant

Interventions

Cilostazol

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)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: March 14, 2014
• Study Start: November 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

KR (1)