Phase 2 Double-blind Evaluation of JTT-251 in Chronic Heart Failure
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JTT-251 Administered for 24 Weeks to Participants with Heart Failure with Reduced Ejection Fraction
IRAS ID
244085
Contact name
Mahadev Ramjee
Contact email
Sponsor organisation
Akros Pharma Inc
Eudract number
2017-005093-19
Clinicaltrials.gov Identifier
Not available, Not available
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
The goal of this study is to determine whether the drug, JTT251, works safely in treating men and women aged 18-85 with heart failure with reduced ejection fraction.
In previous human studies, JTT-251 was considered generally safe and well tolerated at single doses up to and including 900 mg and at repeated daily dose for 14 days up to 600 mg. This study will test three doses of JTT-251; 50 mg, 150 mg and 300 mg given daily for 24 weeks. A new drug always has potential risks but this study will continuously assess safety and effectiveness of the drug while you are participating in it.
Roughly 400 participants will take part in this study. Each participant will be in the study for estimated 32-week period, consisting of a 4-week screening period, a 24-week treatment period and a 4-week follow-up period. There are total 7 visits to attend within this time.
To test whether JTT-251 is safe and effective, it will be compared to a placebo. Participants will be randomly assigned to either take JTT-251 or placebo throughout the study. Neither the study team (doctors and nurses), nor the participant will know which one they are given, to produce valid and unbiased results. This design is referred to as a double-blind placebo-controlled study.
Clinical assessments will be performed at each study visit for both safety and investigative reasons. These include blood tests, urine tests, vital signs measurements, electrocardiogram recording and questionnaires (non-exhaustive list). The study is explained in detail by the study doctor to each potential participant.
Participants will receive their standard medical care throughout the study. Whilst no benefits can be guaranteed, taking part could be beneficial to participants and will help progress research into treatment for the patient population.REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/2104
Date of REC Opinion
11 Dec 2018
REC opinion
Unfavourable Opinion