Chronic heart failure with reduced ejection fraction MedDRA version: 20.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849
Conditions
Interventions
Product Name: Omecamtiv mecarbil
Product Code: AMG 423
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Omecamtiv Mecarbil
CAS Number: 873697-71-3
Current Sponsor code: AMG 423
Other
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are eligible to be included in the study only if all of the following criteria apply: 101 Subject has provided GALACTIC-HF PTA informed consent prior to initiation of any study specific activities/procedures. 102 Subject has completed GALACTIC-HF. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 480 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 665
Exclusion criteria
Exclusion criteria: Subjects are excluded from the study if any of the following criteria apply: 201 Investigational product was permanently discontinued during GALACTIC-HF due to protocol-specified reason. 202 Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 days after the last dose of treatment. 203 Female subjects of childbearing potential unwilling to use 2 acceptable methods of effective contraception during treatment with OM and for an additional 5 days after the last dose of treatment. Refer to Section 11.5 for additional contraceptive information. 204 Female subjects of childbearing potential with a positive pregnancy test assessed on day 1 by a urine pregnancy test. 205 Subject has known sensitivity to any of the products or components to be administered during dosing. 206 History or evidence of any clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Provide access to omecamtiv mecarbil for subjects who have completed GALACTIC-HF 20110203;Secondary Objective: NA;Primary end point(s): There are no endpoints linked to the primary objetive;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Argentina, Brazil, Chile, Mexico, Portugal, Turkey
Contacts
Public ContactMedical Information Department
Amgen Biofarmacêutica, Lda.
Outcome results
None listed