ZO-SA0 PhaseIII clinical trial
- Conditions
- Cardiovascular disease
- Registration Number
- JPRN-jRCT1080222354
- Lead Sponsor
- Zeria Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 60
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).
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Incidence of adverse events and adverse drug reactions
- Secondary Outcome Measures
Name Time Method efficacy<br>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