Клинические исследования в Украине

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Исследования / № 01047683

Краткое названиеEfficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ?‰? 500 and ?‰¤ 2000 mg/dL
Полное названиеEvaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ?‰? 500 mg/dL and ?‰¤ 2000 mg/dL
СпонсорAmarin Pharma Inc.
ИсточникAmarin Pharma Inc.
Под контролемUnited States: Food and Drug Administration
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health and Social Development of the Russian Federation
South Africa: Medicines Control Council
Ukraine: Ministry of Health
Краткое описаниеThe primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared
to placebo in lowering fasting triglyceride levels in patients with very high fasting
triglyceride levels ?‰? 500 and ?‰¤ 2000 mg/dL.
СостояниеАктивный, набор окончен
Дата началаDecember 2009
ФазаPhase 3
Вид исследованияAllocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
КритерииInclusion Criteria:

- Men and women, ages >18

- Fasting triglyceride ?‰?500 mg/dL and ?‰¤2000 mg/dL

- Provide written informed consent and authorization for protected health information

Exclusion Criteria:

- Women who are pregnant or lactating, or planning to become pregnant

- Use of non-statin lipid-altering drugs which cannot be stopped including fibrates,
niacin, fish oil and other products containing omega-3 fatty acids or other dietary
supplements with potential lipid-altering effects

- History of pancreatitis

- History of bariatric surgery or currently on weight loss drugs

- Uncontrolled hypertension (BP > 160/100)

- HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or

- Consumption of more than 2 alcoholic beverages per day

- History of cancers (except if been disease free for >5 years OR history was basal or
squamous cell skin cancer)

- Participation in another clinical trial involving an investigational agent in the
last 30 days

- Other parameters will be assessed at the study center to ensure eligibility for this
Минимальный возраст18 Years
Максимальный возрастN/A
Применяемое лечение
DrugAMR101 (ethyl icosapentate)
DrugAMR101 (ethyl icosapentate)
Контакты и расположение
Ivano-Frankivsk , 76018Ivano-Frankivsk State Medical University
Kiev , 3680Institute of Cardiology
Kyiv , 4114Institute of Gerontology
Odessa , 65059Railway Clinical Hospital, Odessa city
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