Clinical Trials Register

Summary
EudraCT Number:	2016-002299-28
Sponsor's Protocol Code Number:	20110203
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-10-18
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2016-002299-28

A.3

Full title of the trial

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

Dvojitě zaslepené, randomizované, placebem kontrolované multicentrické klinické hodnocení k posouzení účinnosti a bezpečnosti omecamtiv mecarbilu z hlediska mortality a morbidity u pacientů s chronickým srdečním selháváním se sníženou ejekční frakcí

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study investigating the use of Omecamtiv Mecarbil on subjects with heart failure

A.3.2

Name or abbreviated title of the trial where available

GALACTIC-HF

A.4.1

Sponsor's protocol code number

20110203

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Amgen Inc
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Amgen Inc
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Amgen s.r.o.
B.5.2	Functional name of contact point	CZ Medical Information
B.5.3	Address:
B.5.3.1	Street Address	Klimentská 1216/46
B.5.3.2	Town/ city	Praha 1
B.5.3.3	Post code	110 02
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	+420 221 773 500
B.5.6	E-mail	eu-cz-medinfo@amgen.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Omecamtiv mecarbil
D.3.2	Product code	AMG 423
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Omecamtiv Mecarbil
D.3.9.1	CAS number	873697-71-3
D.3.9.2	Current sponsor code	AMG 423
D.3.9.3	Other descriptive name	OMECAMTIV MECARBIL
D.3.9.4	EV Substance Code	SUB79172
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Omecamtiv mecarbil
D.3.2	Product code	AMG 423
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Omecamtiv Mecarbil
D.3.9.1	CAS number	873697-71-3
D.3.9.2	Current sponsor code	AMG 423
D.3.9.3	Other descriptive name	OMECAMTIV MECARBIL
D.3.9.4	EV Substance Code	SUB79172
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	37.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Omecamtiv mecarbil
D.3.2	Product code	AMG 423
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Omecamtiv Mecarbil
D.3.9.1	CAS number	873697-71-3
D.3.9.2	Current sponsor code	AMG 423
D.3.9.3	Other descriptive name	OMECAMTIV MECARBIL
D.3.9.4	EV Substance Code	SUB79172
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic Heart Failure With Reduced Ejection Fraction

E.1.1.1

Medical condition in easily understood language

Chronic Heart Failure

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10008908
E.1.2	Term	Chronic heart failure
E.1.2	System Organ Class	100000004849

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on the time to cardiovascular (CV) death or first HF event, whichever occurs first, in subjects with chronic HF with reduced ejection fraction (HFrEF) receiving standard of care (SoC) therapy.

An HF event is defined as presentation of the patient for an urgent, unscheduled clinic/office/ED visit, or hospital admission, with a primary diagnosis of HF, where the patient exhibits new or worsening symptoms of HF on presentation, has objective evidence of new or worsening HF, and receives initiation or intensification of treatment specifically for HF (Hicks et al, 2015). Changes to oral diuretic therapy do not qualify as initiation or intensification of treatment.

E.2.2

Secondary objectives of the trial

To evaluate the effects of OM on time to:
- CV death
- HF hospitalization
- all-cause death

To evaluate the effects of treatment with OM on change in patient-reported outcomes (PROs).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subject has provided informed consent
Male or female, ≥ 18 to ≤ 85 years of age at signing of informed consent
History of chronic HF (defined as requiring treatment for HF for a
minimum of 30 days before randomization)
LVEF ≤ 35%, per subject's most recent medical record, within 12 months
prior to screening. The most recent qualifying LVEF must be at least 30 days
after any of the following, if applicable: 1) an event likely to decrease EF
(eg, myocardial infarction, sepsis); 2) an intervention likely to increase
EF
(eg, cardiac resynchronization therapy, coronary revascularization); or
3) the first ever presentation for HF.
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
Oral SoC therapies for chronic HF (eg, beta blockers, renin-angiotensinaldosterone
system inhibitors) should be present, if not
contraindicated. Subjects enrolled during either HF hospitalization or
early after HF hospitalization discharge can be reinitiating or titrating
oral SoC chronic HF therapies at the same time of randomization with
the goal of achieving optimized therapy on study.
Currently hospitalized with primary reason of HF OR one of the following
events within 1 year to screening: 1) hospitalization with primary reason
of
HF; 2) urgent visit to ED with primary reason of HF
B-type natriuretic peptide (BNP) level ≥ 125 pg/mL or an NT-proBNP
level ≥ 400 pg/mL at most recent screening assessment (subjects
receiving
angiotensin receptor-neprilysin inhibitor [ARNi] must use NT-proBNP
assessment; for subjects in atrial fibrillation/flutter at screening, the cut
off
levels are: BNP ≥ 375 pg/mL or NT-proBNP ≥ 1200 pg/mL)

E.4

Principal exclusion criteria

Factors expected to interfere with the subject's availability or ability to
complete all protocol-required study visits or procedures, and/or to
comply with
all required study procedures to the best of the subject and
investigator's knowledge (including ongoing substance abuse).
Inability to swallow study medication tablet (eg, swallowing disorders,
feeding tubes)
Receiving mechanical hemodynamic support (eg, intra-aortic balloon
pump counterpulsation), or invasive mechanical ventilation ≤ 7 days
prior to
randomization
Receiving IV inotropes (eg, dobutamine, milrinone, levosimendan) or IV
vasopressors (eg, epinephrine, norepinephrine, dopamine, or
vasopressin)
≤ 3 days prior to randomization
Receiving IV diuretics or IV vasodilators, supplemental oxygen therapy,
or non-invasive mechanical ventilation (eg, bilevel positive airway
pressure
[BiPAP] or continuous positive airway pressure [CPAP] ≤ 12 hours prior
to randomization (Note: the use of non-invasive ventilation for sleep
disordered breathing is permitted)
Acute coronary syndrome (ST-elevation myocardial infarction, non-ST elevation myocardial infarction, unstable angina), stroke, or transient
ischemic attack, major cardiac surgery or cardiac intervention (ie,
implantation of cardiac closure devices, cardiac resynchronization
therapy, or catheter ablation), percutaneous coronary intervention, or
valvuloplasty/other cardiac valve repair or implantation within the 3
months prior to randomization
Insertion of other cardiac devices (eg, implantable cardioverter
defibrillator, permanent pacemaker, monitoring devices) within 30 days
prior to
randomization
Severe uncorrected valvular heart disease, hypertrophic or infiltrative
cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically
significant congenital heart disease

E.5 End points

E.5.1

Primary end point(s)

Composite of time to CV death or first HF event, whichever occurs first.

E.5.1.1

Timepoint(s) of evaluation of this end point

Duration of trial

E.5.2

Secondary end point(s)

Time to CV death.
Change in Kansas City Cardiomyopathy Questionnaire Total Symptoms Score (KCCQ TSS) from baseline to Week 24.
Time to first HF hospitalization.
Time to all-cause death.

E.5.2.1

Timepoint(s) of evaluation of this end point

Duration of trial

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

322

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Australia

Austria

Belgium

Brazil

Bulgaria

Canada

Chile

China

Colombia

Czech Republic

Denmark

France

Germany

Greece

Hungary

Italy

Japan

Mexico

Netherlands

New Zealand

Poland

Portugal

Romania

Russian Federation

Slovakia

South Africa

Spain

Sweden

Switzerland

Turkey

Ukraine

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of study is when the last subject has completed the end of study assessments.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

7457

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

828

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

270

F.4.2

For a multinational trial

F.4.2.1

In the EEA

4191

F.4.2.2

In the whole clinical trial

8285

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-01-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-12-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-09-14

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