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Steroids

Phase 3

Cardiovascular Diseases | Small molecule | Infectious Disease |Elevance Health, Inc.|Last Updated: Mar 4, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment199

FDA Designations

No designations recorded

Clinical trial landscape

Steroids · 1 trial · 4 indications

Phase 3 1
NCT00132080Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart NetworkCardiovascular Diseases
COMPLETED199 Analytics
PHASE3COMPLETED
Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network
Cardiovascular DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Compare the effect of IVMP plus IVIG to IVIG alone on coronary artery outcomes
Measured 5 weeks post-randomization

Secondary Endpoints

Occurrence of CA aneurysms; individual z scores of the LMCA, proximal RCA, and proximal LAD CA at 1 and 5 weeks; changes in absolute coronary dimensions for all CA segments from baseline to 1 and 5 weeks after randomization
Measured 5 weeks post-randomization
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATORPatients with acute Kawasaki disease

Interventions

NameTypeDescription
SteroidsDRUGThis study evaluates the efficacy and safety of pulse steroid therapy, when added to conventional treatment with IVIG plus aspirin, in treatment of children with acute Kawasaki disease.
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Eligibility Criteria

Age Range6 Months to 18 Years
SexALL
Healthy VolunteersNo

* Fever persisting at least 4 days and the presence of at least 4 of the following 5 principal features: 1. Changes in extremities: Acute changes include erythema and edema of hands and feet; Convalescent changes include membranous desquamation of fingertips 2. Polymorphous exanthema 3. Bilat...

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Frequently asked questions about Steroids

What is Steroids used for in Cardiovascular Diseases?

Steroids is an investigational small molecule being studied for use in cardiovascular diseases, specifically in the context of Kawasaki disease. The therapy is being evaluated to address conditions including coronary aneurysm and heart diseases associated with infection. It is currently in Phase 3 clinical development.

Who makes Steroids?

Steroids is being developed by Elevance Health, Inc., a company traded on the stock exchange under the ticker symbol ELV. The company is conducting clinical research on this investigational therapy for cardiovascular diseases.

What phase is Steroids in?

Steroids is currently in Phase 3 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for cardiovascular diseases.

What clinical trials is Steroids in?

Steroids has one completed Phase 3 clinical trial registered under NCT00132080, titled 'Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network'. This randomized, double-blind, placebo-controlled trial enrolled 199 participants aged 6 months and older.

Is Steroids FDA approved?

Steroids is not FDA approved. It is an investigational therapy currently in Phase 3 clinical development for cardiovascular diseases. The therapy has completed one clinical trial but has not yet received regulatory approval for any indication.