Cardiovascular disease
Conditions
Interventions
investigational material(s)
Generic name etc : ZO-SA0
INN of investigational material : -
Therapeutic category code : 219 Other cardiovascular agents
Dosage and Administration for Investigational mate
Sponsors
Zeria Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with cardiovascular disease. Out-patients who signed a written informed consent. If patient age is under 20 years old, a written informed consent have to be obtained from both participant and his/her parent(s).
Exclusion criteria
Exclusion criteria: Patients with or have a history of heart failure, renal failure, nephrotic syndrome, hepatic cirrhosis, thyroid disease Patients with or have a history of lymphoedema, or patients have a history of pelvic surgery Patients with allergic oedema or drug-induced oedema Patients with or have a history of peripheral arterial disease, acute phlebitis, congenital vascular anomaly Patients with or a history of venous thromboembolism Patients who had lower leg surgery, venous sclerotherapy, or compression therapy within 4 weeks before receipt of informed consent Patients who received treatment indicated for lower leg oedema, or treatment to improve lower leg oedema or subjective symptoms associated with lower leg oedema within 4 weeks before receipt of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Incidence of adverse events and adverse drug reactions | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Circumferential change of lower legs, Volume change of lower legs, Subjective symptom VAS score, Changes of subjective symptom VAS score, Improvement rate of general improvement effect by subject, Improvement rate of general improvement effect by doctor | — |
Countries
Japan
Outcome results
None listed