NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1080222354

Registered date:06/01/2014

ZO-SA0 PhaseIII clinical trial

Basic Information

Recruitment status completed
Health condition(s) or Problem(s) studiedCardiovascular disease
Date of first enrollment29/01/2014
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
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 Outcomesafety Incidence of adverse events and adverse drug reactions
Secondary Outcomeefficacy 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
GenderBoth
Include criteriaPatients 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 criteriaPatients 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

Contact

Public contact
Name
Address
Telephone +81-3-5644-7053
E-mail
Affiliation Zeria Pharmaceutical Co., Ltd.
Scientific contact
Name
Address 10-11, Nihonbashi Kobuna-cho, Chuo-ku, Tokyo
Telephone
E-mail
Affiliation Zeria Pharmaceutical Co., Ltd.