D017202 Clinical Trial
Official title:
Phase I Trial of ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
Ischemic cardiomyopathy undergoing coronary artery bypass surgery
| Status | Recruiting |
| Enrollment | 6 |
| Est. completion date | October 31, 2021 |
| Est. primary completion date | April 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 80 Years |
| Eligibility | Inclusion Criteria: 1. Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG 2. Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent 3. Others Exclusion Criteria: 1. Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure 2. Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator 3. Others |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Osaka University Hospital | Suita | Osaka |
| Lead Sponsor | Collaborator |
|---|---|
| Osaka University | Rohto Pharmaceutical Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with Adverse event | Safety assessment related to adverse events and this product | 26 weeks | |
| Primary | Amount of change in late gadolinium contrast-enhanced area at the time of screening and 6 months after surgery | Efficacy (Exploratory) | 26 weeks | |
| Primary | Number of complication associated with drug administration method | Feasibility of drug administration method | 26 weeks |