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Midodrine

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials3
Total Enrollment97

FDA Designations

No designations recorded

Clinical trial landscape

Midodrine · 3 trials · 1 indication

Phase 1 3
NCT00648440Food Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mgHealthy
COMPLETED36 Analytics
NCT00650364Fasting Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mgHealthy
COMPLETED38 Analytics
NCT00650013Fed Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mgHealthy
COMPLETED23 Analytics
PHASE1COMPLETED
Food Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fed Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMidodrine HCl Tablets 5 mg
2ACTIVE_COMPARATORProAmatine® Tablets 5 mg

Interventions

NameTypeDescription
Midodrine HCl Tablets 5 mgDRUG5mg, single dose fed
ProAmatine® Tablets 5 mgDRUG5mg, single dose fed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum Beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and the evening prior ...

Countries:United States
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Frequently asked questions about Midodrine

What is Midodrine used for?

Midodrine is a small molecule drug being developed by Viatris Inc. (VTRS). It is currently in Phase 1 clinical development, with studies conducted in healthy volunteers. The drug is being investigated for its effects in healthy individuals, and the development program includes three completed Phase 1 trials.

Who makes Midodrine?

Midodrine is developed by Viatris Inc., a company traded on the stock exchange under the ticker symbol VTRS. The drug is currently in Phase 1 clinical development, with all three trials completed. These trials were conducted in the United States and enrolled a total of 97 healthy volunteers.

What phase is Midodrine in?

Midodrine is in Phase 1 clinical development. All three of its clinical trials have been completed, with a total enrollment of 97 participants. The trials were conducted in the United States and involved healthy volunteers aged 18 years and older.

What clinical trials is Midodrine in?

Midodrine has three completed Phase 1 clinical trials: NCT00648440, a food study of Midodrine HCl Tablets 5 mg and ProAmatine Tablets 5 mg with 36 participants; NCT00650013, a fed study with 23 participants; and NCT00650364, a fasting study with 38 participants. All trials were conducted in the United States.

Is Midodrine the same as ProAmatine?

Midodrine is being studied in comparison to ProAmatine in clinical trials. The trials NCT00648440, NCT00650013, and NCT00650364 are food, fed, and fasting studies, respectively, that compare Midodrine HCl Tablets 5 mg with ProAmatine Tablets 5 mg in healthy volunteers.