Phase 2 Study with AMG 423 in Acute Heart Failure
Research type
Research Study
Full title
A Double-blind, Randomised, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalised for Acute Heart Failure
IRAS ID
63052
Contact name
John Cleland
Sponsor organisation
Amgen Inc.
Eudract number
2010-021003-24
Clinicaltrials.gov Identifier
Research summary
This is a multicentre, randomised, double-blind, placebo-controlled study with 3 groups enrolled in sequence in order of increasing dose strength of omecamtiv mecarbil (AMG 423). The main aim of the study is to evaluate the effect of AMG423 compared with placebo on breathlessness in patients admitted to hospital with acute heart failure. In each group, subjects are randomised 1:1 to receive omecamtiv mecarbil or a placebo. The safety risk to study subjects will be assessed on an ongoing basis through regular review of unblinded data by an independent Data Monitoring Committee (DMC). Subjects will be enrolled within 16 hours after entering hospital with acute heart failure. Randomisation will be divided by region and by planned participation in the pharmacokinetic/pharmacodynamic (PK/PD) substudy. Omecamtiv mecarbil or placebo will be infused intravenously (directly into a vein) over 48 hours (4 hours loading infusion, followed by 44 hours maintenance infusion). Subjects will stay in hospital for at least 24 hours after the intravenous infusion ending. Evaluations are scheduled at 2, 4, and 6 hours, once between 12 and 18 hours, and then daily until release or 7 days after initiation of investigational product (study day 8), whichever is earlier, and on the day of release from inpatient treatment. Active study participation of an enrolled subject ends with an end-of-study visit at day 30. For a mortality analysis, the investigator will get the vital status of the subject at month 6 and, if deceased, will get the date and reported cause of death.At some sites, subjects will be invited to participate in a PK/PD substudy with additional blood sampling for PK analysis and with echocardiography imaging.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
11/LO/0886
Date of REC Opinion
26 Aug 2011
REC opinion
Further Information Favourable Opinion