Chronic critical limb ischemia associated with arteriosclerosis obliterans
Conditions
Interventions
NK-104-NP 0.5 mg/body
NK-104-NP 1 mg/body
NK-104-NP 2 mg/body
NK-104-NP 4 mg/body
Sponsors
AMED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria before enrollment and who give written consent 1)Patients with Fontaine grades III or IV (generally ABI 0.90, TBI 0.60 or less) 2)Patients with difficulty in revascularization of the femoral artery or below, who do not show improvement in Fontaine classification with 2 weeks of drug therapy (vasodilatators, anti-platelet agents, or prostaglandins) 3)Patients aged 20 years or older at the time of consent
Exclusion criteria
Exclusion criteria: 1) Rutherford grade 3 category 6 2)Malignant tumor or patients who underwent malignant tumor operation within the past 5 years 3)Patients scheduled for surgery for ulcers caused by chronic critical limb ischemia 4)Patients who used anticoagulants within 3 days before starting the administration of the test product. 5)Patients taking a statin. 6)Patients taking a fibrate 7)Patients taking ciclosporins 8)Patients with severe cardiac function disturbance or heart failure 9)Patients with untreated severe arrhythmias 10)Patients with a history of prosthetic valve replacement 11)Patients with progressive hepatic dysfunction 12)Patients with moderate or severe hepatic dysfunction associated with chronic hepatitis. 13)Patients diagnosed with hepatic cirrhosis of Child score B or C 14)Patients with clear findings of interstitial pneumonia 15)Patients with biliary obstruction 16)Patients with a CK high level 17)Patients with a history of hypersensitivity or a serious adverse drug reaction to pitavastatin calcium 18)Patients with a history of serious drug allergy 19)Patients with alcohol dependence or drug dependence 20) others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: names, severity, and incidence rates of adverse events and adverse drug reactions Pharmacokinetics: concentrations of pitavastatin and pitavastatin lactone in plasma and urine, Efficacy: Fontaine classification and Rutherford classification | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: physiological tests (body weight, body temperature, blood pressure, and pulse), clinical laboratory tests, and cardiac function tests Efficacy: ankle-brachial index (ABI) in the supine position, toe-brachial index (TBI) in the supine position, ankle pressure (AP) in the supine position, pulse volume recording (PVR), laser Doppler blood flow, angiography (IA-DSA), ulcer size, degree of pain (VAS), transcutaneous oxygen pressure (TcPO2), number of cases of minor amputation, number of cases of major amputation | — |
Countries
Japan
Contacts
Public ContactTadashi Furuyama
Kyushu University Hospital Kyushu University Graduate School of Medical Sciences
Outcome results
None listed