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Adjusted LOA
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Olive oil · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| Olive Oil | PLACEBO_COMPARATOR | olive oil: 4 g/day + prescription statin |
| Epanova, 2 g | EXPERIMENTAL | omega-3-carboxylic acids, 2g/day + prescription statin |
| Epanova, 4 g | EXPERIMENTAL | omega-3-carboxylic acids, 4g/day + prescription statin |
| Name | Type | Description |
|---|---|---|
| Olive oil, 4g | DRUG | Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin |
| omega-3-carboxylic acids, 2g | DRUG | Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin |
| omega-3-carboxylic acids, 4g | DRUG | Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin |
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...
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.
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.
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.
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.
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.