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Albendazole and/or Vitamin a

Phase 3

Malnutrition | Small molecule | Metabolic |United Therapeutics Corporation|Last Updated: Nov 7, 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment4,000

FDA Designations

No designations recorded

Clinical trial landscape

Albendazole and/or Vitamin a · 1 trial · 3 indications

Phase 3 1
NCT00396500Deworming and Vitamin A (DEVTA) Prepilot StudyMalnutrition
COMPLETED4,000 Analytics
PHASE3COMPLETED
Deworming and Vitamin A (DEVTA) Prepilot Study
MalnutritionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in weight in 2 years

Secondary Endpoints

Secondary: Weight and Height gain in underweight, stunted and wasted children
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeHEALTH_SERVICES_RESEARCH

Interventions

NameTypeDescription
Albendazole (400 mg) and/or Vitamin aDRUG -
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Eligibility Criteria

Age Range1 Year to 5 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Local residents * Aged 1-5 years * Informed written parental consent Exclusion Criteria: * Refusal to give consent * prior enrollment in the study

Countries:India
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Frequently asked questions about Albendazole and/or Vitamin a

What is Albendazole and/or Vitamin A used for?

Albendazole and/or Vitamin A is being studied for use in malnutrition, specifically in children under five years of age with worm infestation. The investigational treatment is in Phase 3 clinical development for this metabolic condition.

Who is developing Albendazole and/or Vitamin A?

United Therapeutics Corporation (NASDAQ: UTHR) is the developer of Albendazole and/or Vitamin A. The company is conducting clinical research on this combination for the treatment of malnutrition in young children.

What phase is Albendazole and/or Vitamin A in?

Albendazole and/or Vitamin A is in Phase 3 clinical development. It is an investigational small molecule treatment for malnutrition and has not been approved by regulatory authorities. The Phase 3 trial has been completed.

What clinical trials is Albendazole and/or Vitamin A in?

Albendazole and/or Vitamin A was studied in the clinical trial NCT00396500, titled "Deworming and Vitamin A (DEVTA) Prepilot Study." This Phase 3 trial enrolled 4,000 participants in India and has been completed.

Is Albendazole and/or Vitamin A a randomized controlled trial?

The Phase 3 trial of Albendazole and/or Vitamin A was randomized but not double-blind, and it used an uncontrolled design. The study enrolled 4,000 participants aged one year and older, including both males and females.