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Niaspan

Phase 1

Dyslipidemia | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Oct 12, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

Niaspan · 2 trials · 1 indication

Phase 1 2
NCT01071291Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)Dyslipidemia
COMPLETED37 Analytics
NCT01104519A Study of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity (0000-093)Dyslipidemia
COMPLETED12 Analytics
PHASE1COMPLETED
Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)
DyslipidemiaUnlock trial analytics
PHASE1COMPLETED
A Study of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity (0000-093)
DyslipidemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in cholesterol efflux
Baseline and 12 weeks
Change from the baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Baseline and 6 weeks
flow-mediated dilation (FMD) of brachial artery
predose, 4 hours post dose and 24 and hours post dose
Nitroglycerin (GTN) induced dilation of brachial artery
predose, 4 hours post dose and 24 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTALArm A will receive a Niaspan treatment in Period 1 and Placebo treatment in Period 2
Arm BEXPERIMENTALArm B will receive a Placebo treatment in Period 1 and Niaspan treatment in Period 2
1EXPERIMENTALNiaspan - Placebo
2EXPERIMENTALPlacebo - Niaspan

Interventions

NameTypeDescription
NiaspanDRUGNiaspan™
Comparator: PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy Male Subjects Exclusion Criteria : * Subject has a history of stroke, chronic seizures, or major neurological disorder * Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respira...

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Frequently asked questions about Niaspan

What is Niaspan used for?

Niaspan is a small molecule being studied for the treatment of dyslipidemia, a condition characterized by abnormal levels of lipids in the blood. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 1 clinical development.

What does Niaspan target?

Niaspan is a small molecule being investigated for dyslipidemia. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied for its effects on lipid levels, including high-density lipoprotein (HDL).

Who makes Niaspan?

Niaspan is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with dyslipidemia.

What phase is Niaspan in?

Niaspan is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 49 participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Niaspan in?

Niaspan has been studied in two completed Phase 1 clinical trials. NCT01071291 evaluated its effects on high-density lipoprotein in healthy male subjects, and NCT01104519 examined its impact on vascular reactivity. Both trials were controlled and double-blind.

Is Niaspan the same as niacin?

Niaspan is a formulation of niacin, also known as vitamin B3, used to treat lipid disorders. In clinical trials, it is being studied for dyslipidemia. The drug is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 1 development.