A Phase 1/2 Study of High-dose Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure [clinicaltrials:NCT02346422]

Bio2RDF identifier

NCT02346422

http://www.w3.org/2001/XMLSchema#string

Bio2RDF namespace

clinicaltrials

http://www.w3.org/2001/XMLSchema#string

Bio2RDF uri

http://bio2rdf.org/clinicaltrials:NCT02346422

http://www.w3.org/2001/XMLSchema#string

identifiers.org URI

NCT02346422

actual enrollment [clinicaltrials_vocabulary:actual-enrollment]

9

http://www.w3.org/2001/XMLSchema#integer

arm group [clinicaltrials_vocabulary:arm-group]

NCT02346422 arm group 1c8147a37c9d06ce96df71081d5fd947 [clinicaltrials_resource:NCT02346422/arm-group/1c8147a37c9d06ce96df71081d5fd947]

NCT02346422 arm group 6f8ce038bc50a5372fcaf86e4b300bb6 [clinicaltrials_resource:NCT02346422/arm-group/6f8ce038bc50a5372fcaf86e4b300bb6]

authority [clinicaltrials_vocabulary:authority]

clinicaltrials_resource:d942c8692d257084abf3ac87279faff6

brief summary [clinicaltrials_vocabulary:brief-summary]

The purpose of this tri ...... and optimized therapy.

http://www.w3.org/2001/XMLSchema#string

brief title [clinicaltrials_vocabulary:brief-title]

A Phase 1/2 Study of High-dose ...... apy for Advanced Heart Failure

http://www.w3.org/2001/XMLSchema#string

clinicaltrials_vocabulary:other outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:other-outcome]

Phase 1 and Phase 2: Safety profile of MYDICAR (proportion of subjects who complete the study; adverse event; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations 24 months [clinicaltrials_resource:0931df2badaa3788046a9a2c6d6045bc]

Phase 1 and Phase 2: Safety profile of MYDICAR (proportion of subjects who complete the study; adverse event; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations 24 months [clinicaltrials_resource:446ae1686e20ad038a9ba49997a6c7ed]

Phase 1 and Phase 2: Safety profile of MYDICAR (proportion of subjects who complete the study; adverse event; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations 24 months [clinicaltrials_resource:47d4c86fd0e66bdb55244f6d1911d1c7]

Phase 1 and Phase 2: Safety profile of MYDICAR (proportion of subjects who complete the study; adverse event; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations 24 months [clinicaltrials_resource:48cdc9ae90748631554c9ec25405510c]

Phase 1 and Phase 2: Safety profile of MYDICAR (proportion of subjects who complete the study; adverse event; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations 24 months [clinicaltrials_resource:ad6f7b0db2084819dca94b8cef22e247]

Phase 1 and Phase 2: Safety profile of MYDICAR (proportion of subjects who complete the study; adverse event; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations 24 months [clinicaltrials_resource:ba98a89e8f571959afaa8330192ff811]

Phase 1 and Phase 2: Safety profile of MYDICAR (proportion of subjects who complete the study; adverse event; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations 24 months [clinicaltrials_resource:d000c796c6f2f32425b01ce3d47171fc]

Phase 1 and Phase 2: Safety profile of MYDICAR (proportion of subjects who complete the study; adverse event; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations 24 months [clinicaltrials_resource:d085b8083d51ebdf0abf595766ef77ae]

Phase 1 and Phase 2: Safety profile of MYDICAR (proportion of subjects who complete the study; adverse event; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations 24 months [clinicaltrials_resource:ffb11a0723887f8ee805c49032fcedbd]

clinicaltrials_vocabulary:primary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:primary-outcome]

Phase 1 and Phase 2: Safety profile of MYDICAR (proportion of subjects who complete the study; adverse event; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations 24 months [clinicaltrials_resource:460e8ddb0695192412054c02eb8af7d9]

completion date [clinicaltrials_vocabulary:completion-date]

2017-11-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

detailed description [clinicaltrials_vocabulary:detailed-description]

Heart failure (HF) is a ...... sly investigated doses.

http://www.w3.org/2001/XMLSchema#string

download date [clinicaltrials_vocabulary:download-date]

ClinicalTrials.gov processed this data on August 10, 2015

http://www.w3.org/2001/XMLSchema#string

eligibility [clinicaltrials_vocabulary:eligibility]

eligibility for clinicaltrials:NCT02346422 [clinicaltrials_resource:e2d32229b2c1fd183383e3da9c8dfee6]

firstreceived date [clinicaltrials_vocabulary:firstreceived-date]

2015-01-15T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

has expanded access [clinicaltrials_vocabulary:has-expanded-access]

No

http://www.w3.org/2001/XMLSchema#string

intervention [clinicaltrials_vocabulary:intervention]

Placebo Phase 2 only [clinicaltrials_resource:279247c279c29193269c993f2d1686e8]

MYDICAR Phase 1 [clinicaltrials_resource:34b29abb05b84f6279369f0fe3bf7216]

MYDICAR Phase 2 [clinicaltrials_resource:bd156b3d901ac4d2d37124ea7843304b]

is fda regulated [clinicaltrials_vocabulary:is-fda-regulated]

Yes

http://www.w3.org/2001/XMLSchema#string

is section 801 [clinicaltrials_vocabulary:is-section-801]

Yes

http://www.w3.org/2001/XMLSchema#string

keyword [clinicaltrials_vocabulary:keyword]

Cardiomegaly

http://www.w3.org/2001/XMLSchema#string

Cardiomyopathies

http://www.w3.org/2001/XMLSchema#string

Cardiovascular Diseases

http://www.w3.org/2001/XMLSchema#string

Gene Therapy

http://www.w3.org/2001/XMLSchema#string

Heart Diseases

http://www.w3.org/2001/XMLSchema#string

Heart Failure

http://www.w3.org/2001/XMLSchema#string

lastchanged date [clinicaltrials_vocabulary:lastchanged-date]

2015-07-06T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

lead sponsor [clinicaltrials_vocabulary:lead-sponsor]

Celladon Corporation [clinicaltrials_resource:90189cf70e43bb7252a2f827109c4736]

location [clinicaltrials_vocabulary:location]

[clinicaltrials_resource:25770ffff17b1bc22c73a6c5d06d91bb]

nct id [clinicaltrials_vocabulary:nct-id]

NCT02346422

http://www.w3.org/2001/XMLSchema#string

number of arms [clinicaltrials_vocabulary:number-of-arms]

2

http://www.w3.org/2001/XMLSchema#integer

official title [clinicaltrials_vocabulary:official-title]

A Phase 1/2 Study of the Safet ...... uble-blind, Placebo-controlled

http://www.w3.org/2001/XMLSchema#string

org study id [clinicaltrials_vocabulary:org-study-id]

CELL-009

http://www.w3.org/2001/XMLSchema#string

overall official [clinicaltrials_vocabulary:overall-official]

Call 1-858-366-4081 [clinicaltrials_resource:ff8d04c91a145324e18e8cc60b0034af]

overall status [clinicaltrials_vocabulary:overall-status]

Terminated [clinicaltrials_resource:fba9c4daa2dd29d1077d32d965320ac1]

oversight [clinicaltrials_vocabulary:oversight]

United States: Food and Drug Administration [clinicaltrials_resource:be4cea82cb21bbda79c939a4d720315b]

phase [clinicaltrials_vocabulary:phase]

Phase 1/Phase 2 [clinicaltrials_resource:72d8d9eabd48f679d5dffa41c4dd93f7]

primary completion date [clinicaltrials_vocabulary:primary-completion-date]

2016-11-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

reference [clinicaltrials_vocabulary:reference]

19327618 [pubmed:19327618]

21709064 [pubmed:21709064]

24065463 [pubmed:24065463]

responsible party [clinicaltrials_vocabulary:responsible-party]

[clinicaltrials_resource:dbd41868ee618d3e64daa1adf8c3a8a0]

source [clinicaltrials_vocabulary:source]

Celladon Corporation [clinicaltrials_resource:90189cf70e43bb7252a2f827109c4736]

start date [clinicaltrials_vocabulary:start-date]

2015-04-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

study design [clinicaltrials_vocabulary:study-design]

clinicaltrials:NCT02346422 study design [clinicaltrials_resource:cfdd182615053aee2c7374a1f5915d22]

study type [clinicaltrials_vocabulary:study-type]

Interventional [clinicaltrials_resource:843ac00ae5d0b7c7defb84fb42c2ce31]

url [clinicaltrials_vocabulary:url]

NCT02346422

verification date [clinicaltrials_vocabulary:verification-date]

2015-07-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

why stopped [clinicaltrials_vocabulary:why-stopped]

Sponsor has suspended clinical development of MYDICAR for heart failure.

http://www.w3.org/2001/XMLSchema#string

identifier

clinicaltrials:NCT02346422

http://www.w3.org/2001/XMLSchema#string

title

A Phase 1/2 Study of High-dose ...... apy for Advanced Heart Failure

@en

inDataset

clinicaltrials_resource:bio2rdf.dataset.clinicaltrials.R3

type

Clinical Study [clinicaltrials_vocabulary:Clinical-Study]

clinicaltrials resource [clinicaltrials_vocabulary:Resource]