A trial to test if CRD-740 is safe and effective for the treatment of chronic heart failure
Research type
Research Study
Full title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Clinical Study to Assess the Effectiveness of CRD-740 in Subjects with Chronic Heart Failure
IRAS ID
1005253
Contact name
Steve Luperchio
Contact email
Sponsor organisation
Cardurion Pharmaceuticals Inc.
Eudract number
2021-005768-23
Clinicaltrials.gov Identifier
Research summary
Summary of Research
The purpose of this study is to find out how safe, tolerable and effective the study drug CRD-740 is for the treatment of heart failure. Heart failure is an ongoing condition in which the heart does not pump blood as well as it should. In addition, the study drug will be compared to a placebo. This study will compare the effects of the study drug to the placebo to see if the study drug has a significant effect in the treatment of heart failure.
The study drug and placebo will be provided, as tablets, that will be taken by mouth.
The study drug is experimental, which means it is not approved by Health Authorities for the treatment of heart failure. The study drug is being developed for the treatment of patients with heart failure.
This study has 2 parts: Part A and Part B. Part A will test 2 different doses of the study drug to determine which dose works best and is tolerated the best. Part B will help to determine if the study drug is effective and if it should be tested in future clinical research studies. About 60 people in Part A and about 600 people in Part B will take part in this study at about 100 different locations internationally.
This study includes Screening period (about 2 weeks), Treatment period (about 12 weeks) and Safety Follow-up period (about 4 weeks). Part A will have 10 study visits. Some visits will be performed remotely within patient’s home or another remote location (by a home health care service provider contracted by the sponsor) or by telemedicine (telephone or video conference). Part B will have 9 study visits. Some visits will be performed remotely by telemedicine.
The total duration of patient’s participation either in Part A or Part B will be about 4 months.
The following tests and procedures will be performed during the study: blood samples, urine sample, vital signs, physical examination, an ECG, an ECHO.
Patient’s participation in the study is voluntary and he/she can decide to stop at any time and for any reason.Summary of Results
The study results have been submitted to clinicaltrials.gov; the results were approved by the Protocol Registration System Administrator and are disclosed publicly.Link to ClinicalTrials.gov Results section: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT05409183%253Fterm%253DNCT05409183%2526rank%253D1%2526tab%253Dresults%2FNBTI%2Fmpe6AQ%2FAQ%2F70049a30-bcca-4558-b66b-0db5ddcb2274%2F1%2Fy0OFYnUpeQ&data=05%7C02%7Capprovals%40hra.nhs.uk%7C34f962ca1a3e444ec73308dd30edf9f3%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638720520840703336%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=yhLWN61sgf8p4YnpkD%2BrilQM%2BmYZevx3XZESqlnMUcM%3D&reserved=0
REC name
West of Scotland REC 1
REC reference
22/WS/0056
Date of REC Opinion
1 Jun 2022
REC opinion
Further Information Favourable Opinion