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acetylsalicylic acid

Phase 1

Hypertriglyceridemia | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Apr 30, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

acetylsalicylic acid · 1 trial · 1 indication

Phase 1 1
NCT01486433The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal SubjectsHypertriglyceridemia
COMPLETED52 Analytics
PHASE1COMPLETED
The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects
Hypertriglyceridemia
NCT0148643352
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Study Endpoints

Primary Endpoints

Area under the plasma concentration versus time curve (AUC0-tau)
14 days

Area under the plasma concentration versus time curve (AUC0-tau)for simvastatin and beta- hydroxysimvastatin acid, measured over the 24 hour period after the 14th dose

Concentration at the end of a dosing interval (Cmax,ss) for simvastatin and beta- hydroxysimvastatin acid,
14 days

Maximum measured plasma concentration for simvastatin and beta- hydroxysimvastatin acid,during the 0-24 hour dosing interval for the 14th simvastatin dose (Day 14)measured over the 24 hour period after the 14th dose.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Epanova and SimvastatinEXPERIMENTAL -
SimvastatinACTIVE_COMPARATOR -

Interventions

NameTypeDescription
SimvastatinDRUG40 mg (1 tablet) simvastatin once a day
acetylsalicylic acid (ASA)DRUG81 mg aspirin (1 tablet), once a day, co-administered with simvastatin
omefasDRUG4 g (4 capsules) Epanova once a day, co-administered with simvastatin and aspirin
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Subjects must fulfil all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified: 1. Healthy adult male or female volunteers, 18-55 years of age, inclusive. 2. Body mass index (BMI) ≥ 18 and ≤ 29.9 (kg/m2). 3. Medically heal...

Countries:United States
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Frequently asked questions about acetylsalicylic acid

What is acetylsalicylic acid used for in hypertriglyceridemia?

Acetylsalicylic acid is being investigated for the treatment of hypertriglyceridemia, a condition characterized by elevated triglyceride levels in the blood. It is a small molecule being developed by AstraZeneca PLC. The drug is currently in Phase 1 clinical development for this metabolic indication.

Who makes acetylsalicylic acid?

AstraZeneca PLC (ticker: AZN) is developing acetylsalicylic acid. The company is conducting clinical trials to evaluate the drug for the treatment of hypertriglyceridemia. Acetylsalicylic acid is a small molecule in Phase 1 development.

What phase is acetylsalicylic acid in?

Acetylsalicylic acid is in Phase 1 clinical development. It is an investigational drug being studied for hypertriglyceridemia. The drug has completed one Phase 1 trial, and it is not yet approved for any use.

What clinical trials is acetylsalicylic acid in?

Acetylsalicylic acid has been studied in one completed clinical trial, NCT01486433. This Phase 1 trial evaluated the effect of multiple doses of Epanova on the pharmacokinetics of simvastatin in healthy subjects with hypertriglyceridemia. The trial enrolled 52 participants in the United States and was active-controlled.

Is acetylsalicylic acid the same as Epanova?

Acetylsalicylic acid is not the same as Epanova. In the clinical trial NCT01486433, Epanova was the drug being tested, and acetylsalicylic acid is a separate compound. The trial studied the interaction between Epanova and simvastatin in healthy subjects with hypertriglyceridemia.