ZO-SA0 PhaseIII clinical trial

JRCT ID: jRCT1080222354

Registered date:06/01/2014

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Cardiovascular disease
• Date of first enrollment: 29/01/2014
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : ZO-SA0
INN of investigational material : -
Therapeutic category code : 219 Other cardiovascular agents
Dosage and Administration for Investigational material : 2 capsules / day

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

safety
Incidence of adverse events and adverse drug reactions

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 74age old
• Gender: Both

Include 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).

Exclude 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

Related Information

• Primary Sponsor: Zeria Pharmaceutical Co., Ltd.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): JapicCTI-142404