Omecamtiv Mecarbil Administered to Patients with Stable Heart Failure
Research type
Research Study
Full title
An Open Label, Multiple Dose Study to Investigate the Pharmacokinetics of Omecamtiv Mecarbil Administered Orally to Patients with Stable Heart Failure
IRAS ID
54872
Contact name
John GF Cleland
Sponsor organisation
Amgen Inc
Eudract number
2009-018000-17
Clinicaltrials.gov Identifier
Research summary
Patients recruited to this study will have stable heart failure(i.e. controlled with medication) . Heart failure is a condition where the heart is unable to pump enough blood to meet the body's requirements. ~30-40% of patients hospitalised with heart failure either die or are re-hopitalised within 1 year. The study drug (Omecamtiv mecarbil) is a novel agent designed to increase the contractility of the heart and improve heart function. The pharmacokinetic data obtained from this study will allow the Sponsor to determine how best to dose this new drug. The study will look at the dose,the dose frequency, the formulation [modified release formulation (MR) or immediate release formulation (IR)]. If results are positive after this study, it will determine the dose range/s that can be studied in the next phase of clinical trials. Each site involved in the UK is a specialist phase I hospital unit (or department within a hospital) Each patient will be in the trial for approximatley 5 weeks (including screening (up to 3 weeks), treatment and follow up (up to 2 weeks duration).
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
10/H0304/50
Date of REC Opinion
12 Jul 2010
REC opinion
Further Information Favourable Opinion