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Olive oil

Phase 3

Hypertriglyceridemia | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Dec 5, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment646

FDA Designations

No designations recorded

Clinical trial landscape

Olive oil · 1 trial · 2 indications

Phase 3 1
NCT01408303[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROLHypertriglyceridemia
COMPLETED646 Analytics
PHASE3COMPLETED
[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL
HypertriglyceridemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Serum Non-HDL Cholesterol
6 weeks

The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Olive OilPLACEBO_COMPARATORolive oil: 4 g/day + prescription statin
Epanova, 2 gEXPERIMENTALomega-3-carboxylic acids, 2g/day + prescription statin
Epanova, 4 gEXPERIMENTALomega-3-carboxylic acids, 4g/day + prescription statin

Interventions

NameTypeDescription
Olive oil, 4gDRUGOlive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin
omega-3-carboxylic acids, 2gDRUGEpanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin
omega-3-carboxylic acids, 4gDRUGEpanova: 4 x 1 g capsule daily for 6 weeks + prescription statin
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites89

Inclusion Criteria: 1. Men or women, ≥18 years of age. 2. Fasting triglyceride (TG) level ≥200 mg/dL and \<500 mg/dL. 3. The subject is a high risk for a future cardiovascular event. 4. The subject is treated with a statin and at or near LDL-C goal. Exclusion Criteria: 1. Allergy or intolerance t...

Countries:United States
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Frequently asked questions about Olive oil

What is Olive oil used for?

Olive oil is being investigated for the treatment of hypertriglyceridemia, a condition of elevated triglycerides, in patients with cardiovascular disease. It is a small molecule being developed as a potential therapy to reduce non-HDL cholesterol in this patient population.

Who makes Olive oil?

Olive oil is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical research to evaluate the drug's safety and efficacy for hypertriglyceridemia.

What phase is Olive oil in?

Olive oil is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under evaluation for its intended use in hypertriglyceridemia.

What clinical trials is Olive oil in?

Olive oil has one completed Phase 3 clinical trial registered under NCT01408303. The trial enrolled 646 participants in the United States and evaluated the drug in patients with hypertriglyceridemia and cardiovascular disease. The study was randomized, double-blind, and placebo-controlled.

Is Olive oil the same as any other drug?

Olive oil is not known to have alternative names. It is being studied under its own name by AstraZeneca for hypertriglyceridemia. No other names for this drug have been reported in the clinical trial information.