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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02929329




Registration number
NCT02929329
Ethics application status
Date submitted
30/09/2016
Date registered
11/10/2016
Date last updated
14/10/2020

Titles & IDs
Public title
Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction
Scientific title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)
Secondary ID [1] 0 0
2016-002299-28
Secondary ID [2] 0 0
20110203
Universal Trial Number (UTN)
Trial acronym
GALACTIC-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Omecamtiv Mecarbil
Treatment: Drugs - Placebo

Experimental: Active Treatment - Oral omecamtiv mecarbil twice daily for up to 208 weeks

Placebo Comparator: Placebo - Oral placebo twice daily for up to 208 weeks


Treatment: Drugs: Omecamtiv Mecarbil
Oral omecamtiv mecarbil twice daily for up to 208 weeks with dose level determined by periodic blood testing

Treatment: Drugs: Placebo
Oral placebo twice daily for up to 208 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Measure time to cardiovascular death or first heart failure event - Evaluate the effect of omecamtiv mecarbil/AMG 423 as compared with placebo in subjects with chronic heart failure with reduced ejection fraction receiving standard of care therapy
Timepoint [1] 0 0
Through study completion, up to 208 weeks
Secondary outcome [1] 0 0
Measure time to cardiovascular death - Evaluate effects of omecamtiv mecarbil/AMG 423 on time to cardiovascular death
Timepoint [1] 0 0
Through study completion, up to 208 weeks
Secondary outcome [2] 0 0
Measure changes in patient reported outcomes Kansas City Cardiomyopathy Questionnaire Total Symptom Score - Evaluate effect of treatment with omecamtiv mecarbil/AMG 423 on changes in patient reported outcomes
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Measure time to first heart failure hospitalization - Evaluate effects of omecamtiv mecarbil/AMG 423 to first heart failure hospitalization
Timepoint [3] 0 0
Through study completion, up to 208 weeks
Secondary outcome [4] 0 0
Measure time to all-cause death - Evaluate effects of omecamtiv mecarbil/AMG 423 to all-cause death
Timepoint [4] 0 0
Through study completion, up to 208 weeks

Eligibility
Key inclusion criteria
Key

- Subject has provided informed consent

- Male or female, = 18 to = 85 years

- History of chronic HF (defined as requiring treatment for HF for a minimum of 30 days
before randomization)

- LVEF = 35%, per subjects most recent medical record, within 12 months prior to
screening.

- NYHA class II to IV at most recent screening assessment.

- Managed with HF SoC therapies consistent with regional clinical practice guidelines
according to investigator judgment of subject's clinical status

- Current hospitalization with primary reason of HF OR one of the following events
within 1 year of screening: hospitalization with primary reason of HF; urgent visit to
emergency department (ED) with primary reason of HF.

- Elevated BNP or NT-proBNP

Other Inclusion Criteria May apply

Key
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Currently receiving treatment in another investigational device or drug study, or < 30
days since ending treatment on another investigational device or drug study(ies).
Other investigational procedures while participating in this study are excluded.

- Malignancy within 5 years prior to randomization with the following exceptions:
localized basal or squamous cell carcinoma of the skin, cervical intraepithelial
neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.

- Subject has known sensitivity to any of the products or components to be administered
during testing

Other Exclusion Criteria May apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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2010 - Darlinghurst
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Japan
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Japan
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Japan
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Romania
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Romania
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Moscow
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Slovakia
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Slovakia
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Presov
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Slovakia
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Slovakia
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Slovakia
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Free State
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Sweden
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Sweden
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Switzerland
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Switzerland
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Switzerland
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Switzerland
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Switzerland
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Switzerland
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Turkey
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Turkey
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Corum
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Turkey
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Eskisehir
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Turkey
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Kocaeli
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Turkey
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Konya
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Turkey
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Mersin
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Turkey
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Turkey
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Sivas
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Turkey
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Van
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Ukraine
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Dnipropetrovsk
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Ukraine
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Ukraine
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Ukraine
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United Kingdom
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Ayr
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United Kingdom
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Basingstoke
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United Kingdom
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Belfast
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United Kingdom
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United Kingdom
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Corby
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United Kingdom
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Cottingham
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United Kingdom
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Dudley
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United Kingdom
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Dundee
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United Kingdom
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Exeter
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United Kingdom
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Gillingham
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United Kingdom
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United Kingdom
State/province [461]