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Revatio

Phase 4FDA approved 2005

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Jan 29, 2021

Revatio development status

FDA approval Jun 3, 2005
Approval holderViatris
ApplicationNDA021845
Highest phase Phase 4 (NCT00430716)
Phase scored for VTRSPhase 1
Registered trials 24 across 4 sponsors since Sep 2005

Label indication Adults REVATIO is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14) ] . FDA label

Revatio target and mechanism

ModalitySmall molecule

Also known as sildenafil citrate, iv sildenafil

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Revatio clinical trials

Revatio · 1 trial · 1 indication

Phase 1 1
NCT01027117A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy VolunteersHealthy
COMPLETED18 Analytics
PHASE1COMPLETED
A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers
Healthy
NCT0102711718
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Study Endpoints

Primary Endpoints

AUClast
Within 14 hours post dose
Cmax
Within 14 hours post dose

Secondary Endpoints

T1/2
Within 14 hours post dose
AUCinf
Within 14 hours post dose
Tmax
Within 14 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Treatment AACTIVE_COMPARATORRevatio 20 mg intact tablet. This is the reference treatment arm.
Treatment BEXPERIMENTALTreatment B: Revatio 20 mg crushed tablet mixed with apple sauce.
Treatment CEXPERIMENTALTreatment C: Revatio 20 mg extemporaneously prepared suspension (EP).

Interventions

NameTypeDescription
RevatioDRUGThree treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male/female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and cli...

Countries:Belgium
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