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L-arginine

Phase 2

Sepsis | Unknown | Infectious Disease |Novartis AG|Trials Updated: Jan 29, 2013

L-arginine development status

Highest phase Phase 2 run by Emory University (NCT02536170)
Phase scored for NVSPhase 1
Registered trials 3 across 3 sponsors since Jan 2013

L-arginine target and mechanism

ModalityUnknown

Also known as L-arginine-HCl

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

L-arginine clinical trials

L-arginine · 1 trial · 2 indications

Early Phase 1 1
NCT01775020Dose-response Study of Arginine Supplementation in Severe SepsisSepsis
COMPLETED8 Analytics
EARLY_PHASE1COMPLETED
Dose-response Study of Arginine Supplementation in Severe Sepsis
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Study Endpoints

Primary Endpoints

Nitric oxide synthesis
8 hours

Nitric oxide synthesis at step-wise increasing doses of L-arginine infusion. Following a 2h baseline measurements, 3 stepwise increasing arginine doses each provided for 2h will be tested for the effect on NO synthesis.

Secondary Endpoints

hemodynamics
8 hours
blood parameters
8 hours
gastric perfusion
8 hours
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
L-arginineEXPERIMENTALL-arginine

Interventions

NameTypeDescription
L-arginineDIETARY_SUPPLEMENT -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Written informed consent from close relative * Age \> 18 years * Patient meets the general criteria for severe sepsis or septic shock, diagnosed less than 48 h prior to study inclusion (see appendix A; in Dutch). * Patient must be relatively hemodynamically stable, defined as ...

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Competitive Landscape -Sepsis 24 trials

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