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SCH 530348

Phase 2

Arterial Obstructive Diseases | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: May 25, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment1,030

FDA Designations

No designations recorded

Clinical trial landscape

SCH 530348 · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT00132912Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)Arterial Obstructive Diseases
COMPLETED1,030 Analytics
PHASE2COMPLETED
Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)
Arterial Obstructive Diseases
NCT001329121,030
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Study Endpoints

Primary Endpoints

Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention
Area under the plasma concentration-time curve from 0 to 72 hours (AUC[0-72h]) of SCH 530348
Up to 72 hours after SCH 530348 dose on Day 5
Maximal plasma concentration (Cmax) of SCH 530348
Up to 72 hours after SCH 530348 dose on Day 5

Secondary Endpoints

Incidence of bleeding throughout treatment and follow-up
Incidence of death and major adverse cardiac events
Number of participants experiencing clinical and laboratory adverse events (AEs)
Up to 2 weeks after last dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Standard PercentageEXPERIMENTAL -
High PercentageEXPERIMENTAL -

Interventions

NameTypeDescription
SCH 530348DRUG -
PantoprazoleDRUG40 mg delayed-release tablet administered orally in the morning of Days 1-7
SCH 530348 (high percentage)DRUG2.5 mg tablet containing \~46% active pharmaceutical ingredient (API) as free base (46+5%) administered orally on the morning of Day 5
SCH 530348 (standard percentage)DRUG2.5 mg tablet containing \~23% API as free base (STANDARD) administered orally on the morning of Day 5
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Eligibility Criteria

Age Range45 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * A person who is 45 years or older and is mentally competent to provide a signed written informed consent. * A person who is scheduled to undergo a percutaneous coronary intervention or a heart catheterization with the intent to undergo a percutaneous coronary intervention. * I...

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Frequently asked questions about SCH 530348

What is SCH 530348 used for?

SCH 530348 is an investigational small molecule being developed for Acute Coronary Syndrome and Arterial Obstructive Diseases, including Coronary Disease. It is in Phase 1 clinical development and is not approved by the FDA.

Who makes SCH 530348?

SCH 530348 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The drug is currently in Phase 1 clinical trials for cardiovascular conditions.

What phase is SCH 530348 in?

SCH 530348 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing to evaluate its safety and other properties.

What clinical trials is SCH 530348 in?

SCH 530348 has been studied in two completed trials. NCT00132912 was a Phase 2 study in subjects undergoing non-emergent percutaneous coronary intervention, and NCT01358344 was a Phase 1 bioequivalence study of 2.5 mg tablets in Acute Coronary Syndrome.

Is SCH 530348 the same as vorapaxar?

SCH 530348 is also known as vorapaxar. It is an investigational drug being developed by Merck & Company, Inc. for cardiovascular conditions such as Acute Coronary Syndrome and Arterial Obstructive Diseases.