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Niacin/Simvastatin

Phase 3

Hyperlipidemia | Small molecule | Cardiovascular |Abbott Laboratories|Last Updated: Jun 13, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment199

FDA Designations

No designations recorded

Clinical trial landscape

Niacin/Simvastatin · 1 trial · 2 indications

Phase 3 1
NCT00465088An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)Hyperlipidemia
COMPLETED199 Analytics
PHASE3COMPLETED
An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)
Hyperlipidemia
NCT00465088199
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Study Endpoints

Primary Endpoints

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12
From baseline to Week 12

(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

Secondary Endpoints

Percent Change in HDL-C From Baseline to Week 8
From baseline to Week 8
Percent Change in Non-HDL-C From Baseline to Week 8
From baseline to Week 8
Percent Change in Non-HDL-C From Baseline to Week 12
From baseline to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -

Interventions

NameTypeDescription
Niacin ER/Simvastatin TabletsDRUGUp to 2000 mg/40 mg at bedtime
atorvastatinDRUG40 mg at bedtime
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites46

Inclusion Criteria: * Subjects must meet all of the following laboratory criteria: * HDL-C \<40 mg/dL for men and \<50 mg/dL for women. * LDL-C ≥130 mg/dL but \<250 mg/dL. * TG \<350 mg/dL. * Creatine phosphokinase (CPK) \< 3 x upper limit of normal (ULN). * Alanine aminotransferase (ALT...

Countries:United States
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Frequently asked questions about Niacin/Simvastatin

What is Niacin/Simvastatin used for?

Niacin/Simvastatin is used for hyperlipidemia, a condition of elevated lipids in the blood. It is being studied in patients with hyperlipidemia or mixed dyslipidemia to compare its lipid effects against atorvastatin. The drug is a small molecule combination therapy in Phase 3 clinical development.

Who makes Niacin/Simvastatin?

Niacin/Simvastatin is being developed by Abbott Laboratories, traded on the New York Stock Exchange under the ticker ABT. The company is conducting clinical trials for this combination therapy in the cardiovascular therapeutic area, specifically targeting hyperlipidemia.

What phase is Niacin/Simvastatin in?

Niacin/Simvastatin is in Phase 3 clinical development. It is an investigational drug, not yet approved, and is being studied for hyperlipidemia. One Phase 3 trial has been completed with 199 participants enrolled, and no active trials are currently listed.

What clinical trials is Niacin/Simvastatin in?

Niacin/Simvastatin has one completed Phase 3 trial, NCT00465088, titled 'An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)'. This controlled, randomized study enrolled 199 adults in the United States.

Is Niacin/Simvastatin FDA approved?

Niacin/Simvastatin is not FDA approved. It is an investigational combination therapy currently in Phase 3 clinical development for hyperlipidemia. The drug has completed one clinical trial, but approval status has not been established, and it remains under investigation.