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Vytorin+ Niaspan

Phase 4

Hypercholesterolemia | Small molecule | Cardiovascular |Organon & Co.|Trials Updated: Feb 16, 2022

Vytorin+ Niaspan development status

Highest phase Phase 4 (NCT00651963)
Phase scored for OGNPhase 1
Registered trials 188 across 49 sponsors since Aug 2001

Vytorin+ Niaspan target and mechanism

ModalitySmall molecule

Also known as SCH 465981, ezetimibe, simvastatin, niacin, nicotinic acid

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

Vytorin+ Niaspan clinical trials

Vytorin+ Niaspan · 1 trial · 2 indications

Phase 1 1
NCT00652431Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2)Hypercholesterolemia
COMPLETED18 Analytics
PHASE1COMPLETED
Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2)
HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the potential for a PK interaction between NIASPAN and components of VYTORIN, using Tmax, Cmax, and AUC.
Day 7

Secondary Endpoints

Evaluate safety and tolerability: laboratory test results, ECGs, adverse events, vital signs.
throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Vytorin + NiaspanEXPERIMENTALNIASPAN 1000 mg (1 x 1000 mg tablet) once-daily in the morning on Days 1 to 2, followed by NIASPAN 2000 mg (2 x 1000 mg tablets) once-daily in the morning on Days 3 to 7 + VYTORIN 10/20 mg (1 x 10/20 mg tablet containing ezetimibe 10 mg and simvastatin 20 mg) once-daily in the morning for 7 days
VytorinACTIVE_COMPARATORVYTORIN 10/20 mg (1 x 10/20 mg tablet containing ezetimibe 10 mg and simvastatin 20 mg) once-daily in the morning for 7 days
NiaspanACTIVE_COMPARATORNIASPAN 1000 mg (1 x 1000 mg tablet) once-daily in the morning on Days 1 to 2, followed by NIASPAN 2000 mg (2 x 1000 mg tablets) once-daily in the morning on Days 3 to 7 for a total of 7 days of treatment

Interventions

NameTypeDescription
Vytorin + NiaspanDRUGVytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days + Niaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7
VytorinDRUGVytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days
NiaspanDRUGNiaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: The subject must meet ALL the criteria listed below for entry: * Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules. * Subjects of either sex and of any race between the ages of 18 and 55 years, inclusive, having a Body Mass...

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Frequently asked questions about Vytorin+ Niaspan

What is Vytorin + Niaspan?

Vytorin + Niaspan refers to a combination treatment approach pairing Vytorin with Niaspan, studied for hypercholesterolemia. Vytorin is a small molecule therapy, and Niaspan is a niacin-based product. The combination has been evaluated in a Phase 1 drug interaction study in healthy subjects rather than as a single fixed-dose product.

What is Vytorin + Niaspan used for?

Vytorin + Niaspan has been studied for hypercholesterolemia and hyperlipidemia, conditions involving elevated cholesterol and lipid levels in the blood. The clinical work on this combination focused on assessing how the two agents interact when used together in healthy adult subjects.

Who makes Vytorin + Niaspan?

Organon & Co. (ticker: OGN) is the developer associated with Vytorin + Niaspan. Organon is the company linked to the clinical program evaluating this combination in hypercholesterolemia.

What phase is Vytorin + Niaspan in?

Vytorin + Niaspan is in Phase 1 development. The program's single recorded trial was a Phase 1 study, and it has been completed. The combination is investigational in this program and is not described as approved for the studied use.

What clinical trials is Vytorin + Niaspan in?

Vytorin + Niaspan has been evaluated in one completed Phase 1 trial, NCT00652431, titled Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2). The study enrolled 18 healthy volunteers aged 18 years and older, was randomized, and used an active-controlled design without blinding.