Trial record 45 of 138 for:    johnstown

Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia (STRENGTH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by AstraZeneca
Sponsor:
Collaborators:
Cleveland Clinic Coordinating Center for Clinical Research (C5R)
Quintiles, Inc.
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02104817
First received: April 2, 2014
Last updated: July 6, 2016
Last verified: July 2016
  Purpose
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.

Condition Intervention Phase
Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
Drug: Epanova® (omega-3 carboxylic acids)
Drug: corn oil control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The primary outcome measure is the time to the first occurrence of any component of the composite of MACE. [ Time Frame: Patients will remain in the study until the required number of MACE has occurred. We anticipate that patients will be in the study for up to 5 years. ] [ Designated as safety issue: No ]
    MACE components include: cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina.


Secondary Outcome Measures:
  • The composite measure of CV events that include the first occurrence of cardiovascular death, non-fatal MI and non-fatal stroke. [ Time Frame: We anticipate that patients will be in the study for up to 5 years. Same for all outcome measures. ] [ Designated as safety issue: No ]
    The secondary outcome measures will be analyzed the same as outlined above for the primary outcome measures.

  • The composite measure of coronary events that include the first occurrence of cardiac death. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The composite measure of coronary events that include the first occurrence of cardiac death ( including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), nonfatal MI, emergent/elective coronary revascularization, or hospitalization for unstable angina.

  • The first occurrence of individual components of MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Time to CV death [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Cardiovascular death includes death resulting from: an acute MI, sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.


Estimated Enrollment: 13000
Study Start Date: October 2014
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPANOVA
Epanova + statin, once daily
Drug: Epanova® (omega-3 carboxylic acids)
Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)
Other Name: omega-3 carboxylic acids
Active Comparator: Corn oil
Corn oil + Statin
Drug: corn oil control
corn oil control arm

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women, ≥18 years of age.
  2. Patient must be on a stable diet and statin* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:

    1. LDL-C <100 mg/dL
    2. TG level ≥180 and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for women
  3. Patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c)* is present via patient history, physical exam, or medical records at the time of screening:

    1. Any atherosclerotic CVD as defined in protocol.
    2. History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50 years of age for women, plus one of the risk factors defined in protocol.
    3. Male patients >50 years of age or females >60 years of age, with at least one of the risk factors defined in protocol.

Key Exclusion Criteria:

1. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil. 2.Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4 weeks prior to Visit 2. 3.Statin naïve at Visit 1.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104817

Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Praha, Czech Republic
Research Site Recruiting
Praha 10 - Strasnice, Czech Republic
Research Site Withdrawn
Praha 2, Czech Republic
Research Site Not yet recruiting
Praha 5, Czech Republic
Research Site Recruiting
Praha 8, Czech Republic
Research Site Recruiting
Prerov, Czech Republic
Research Site Withdrawn
Semily, Czech Republic
Research Site Recruiting
Slany, Czech Republic
Research Site Recruiting
Tremosna, Czech Republic
Research Site Recruiting
Trutnov, Czech Republic
Research Site Recruiting
Zlin, Czech Republic
Denmark
Research Site Recruiting
Frederiksberg, Denmark
Research Site Recruiting
Hellerup, Denmark
Research Site Recruiting
Herlev, Denmark
Research Site Not yet recruiting
Hillerød, Denmark
Research Site Recruiting
København Ø, Denmark
Research Site Withdrawn
Køge, Denmark
Research Site Recruiting
Svendborg, Denmark
Research Site Recruiting
Viborg, Denmark
Research Site Recruiting
Ålborg, Denmark
Research Site Recruiting
Århus N, Denmark
Estonia
Research Site Recruiting
Haabneeme, Estonia
Research Site Recruiting
Pärnu, Estonia
Research Site Recruiting
Tallinn, Estonia
Research Site Withdrawn
Tallinn, Estonia
Research Site Recruiting
Tartu, Estonia
Hungary
Research Site Withdrawn
Baja, Hungary
Research Site Recruiting
Baja, Hungary
Research Site Recruiting
Balatonfured, Hungary
Research Site Recruiting
Balatongyorok, Hungary
Research Site Recruiting
Ballasagyarmat, Hungary
Research Site Recruiting
Bekescsaba, Hungary
Research Site Recruiting
Budapest, Hungary
Research Site Withdrawn
Budapest, Hungary
Research Site Recruiting
Csorna, Hungary
Research Site Recruiting
Debrecen, Hungary
Research Site Recruiting
Eger, Hungary
Research Site Recruiting
Godollo, Hungary
Research Site Not yet recruiting
Gyomro, Hungary
Research Site Not yet recruiting
Gyongyos, Hungary
Research Site Withdrawn
Győr, Hungary
Research Site Recruiting
Gödöllő, Hungary
Research Site Recruiting
Hajdúszoboszló, Hungary
Research Site Not yet recruiting
Hodmezovasarhely, Hungary
Research Site Withdrawn
Hódmezovásárhely, Hungary
Research Site Recruiting
Kalocsa, Hungary
Research Site Recruiting
Kiskunhalas, Hungary
Research Site Recruiting
Komarom, Hungary
Research Site Not yet recruiting
Komarom, Hungary
Research Site Recruiting
Létavértes, Hungary
Research Site Recruiting
Mohacs, Hungary
Research Site Recruiting
Nagykanizsa, Hungary
Research Site Recruiting
Nyiregyhaza, Hungary
Research Site Recruiting
Nyíregyháza, Hungary
Research Site Recruiting
Szeged, Hungary
Research Site Recruiting
Szekszárd, Hungary
Research Site Recruiting
Szentes, Hungary
Research Site Recruiting
Székesfehérvár, Hungary
Research Site Recruiting
Veszprem, Hungary
Research Site Withdrawn
Zalaegerszeg, Hungary
Research Site Recruiting
Zalaegerszeg, Hungary
Italy
Research Site Recruiting
Bergamo, Italy
Research Site Recruiting
Bologna, Italy
Research Site Recruiting
Brescia, Italy
Research Site Not yet recruiting
Caserta, Italy
Research Site Recruiting
Cinisello Balsamo, Italy
Research Site Recruiting
Cona, Italy
Research Site Withdrawn
Foggia, Italy
Research Site Withdrawn
Genova, Italy
Research Site Suspended
Genova, Italy
Research Site Recruiting
L'Aquila, Italy
Research Site Recruiting
Milano, Italy
Research Site Recruiting
Napoli, Italy
Research Site Withdrawn
Padova, Italy
Research Site Recruiting
Parma, Italy
Research Site Recruiting
Pavia, Italy
Research Site Recruiting
Perugia, Italy
Research Site Recruiting
Roma, Italy
Research Site Recruiting
San Giovanni Rotondo, Italy
Research Site Recruiting
Trieste, Italy
Japan
Research Site Recruiting
Adachi-ku, Japan
Research Site Recruiting
Akishima-shi, Japan
Research Site Recruiting
Akita-shi, Japan
Research Site Recruiting
Amagasaki-shi, Japan
Research Site Recruiting
Chikushi-gun, Japan
Research Site Recruiting
Chikushino-shi, Japan
Research Site Recruiting
Chuo-ku, Japan
Research Site Recruiting
Fujisawa-shi, Japan
Research Site Recruiting
Gifu-shi, Japan
Research Site Recruiting
Hachioji-shi, Japan
Research Site Recruiting
Hakusan-shi, Japan
Research Site Recruiting
Ichikawa-shi, Japan
Research Site Recruiting
Imabari-shi, Japan
Research Site Recruiting
Itoshima-shi, Japan
Research Site Not yet recruiting
Kagoshima-shi, Japan
Research Site Withdrawn
Kashiwa-shi, Japan
Research Site Recruiting
Kasugai-shi, Japan
Research Site Recruiting
Kawanishi-shi, Japan
Research Site Recruiting
Kishiwada-shi, Japan
Research Site Recruiting
Kitakyushu-shi, Japan
Research Site Recruiting
Kochi-shi, Japan
Research Site Recruiting
Kyoto-shi, Japan
Research Site Recruiting
Maebashi-shi, Japan
Research Site Withdrawn
Matsubara-shi, Japan
Research Site Recruiting
Matsudo-shi, Japan
Research Site Recruiting
Matsumoto-shi, Japan
Research Site Recruiting
Matsuyama-shi, Japan
Research Site Recruiting
Meguro-ku, Japan
Research Site Recruiting
Minato-ku, Japan
Research Site Recruiting
Nagoya-shi, Japan
Research Site Not yet recruiting
Nerima-ku, Japan
Research Site Recruiting
Niigata-shi, Japan
Research Site Recruiting
Oita-shi, Japan
Research Site Recruiting
Okinawa-shi, Japan
Research Site Recruiting
Onga-gun, Japan
Research Site Recruiting
Osaka-shi, Japan
Research Site Withdrawn
Osaka-shi, Japan
Research Site Recruiting
Saga-shi, Japan
Research Site Recruiting
Sapporo-shi, Japan
Research Site Recruiting
Sendai-shi, Japan
Research Site Recruiting
Shinagawa-ku, Japan
Research Site Recruiting
Shinjuku-ku, Japan
Research Site Recruiting
Takamatsu-shi, Japan
Research Site Recruiting
Takasaki-shi, Japan
Research Site Recruiting
Tokorozawa-shi, Japan
Research Site Recruiting
Toshima-ku, Japan
Research Site Recruiting
Tsuchiura-shi, Japan
Research Site Recruiting
Yokohama-shi, Japan
Korea, Republic of
Research Site Recruiting
Busan, Korea, Republic of
Research Site Withdrawn
Daejeon, Korea, Republic of
Research Site Not yet recruiting
Daejeon, Korea, Republic of
Research Site Recruiting
Gwangju, Korea, Republic of
Research Site Recruiting
Incheon, Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of
Research Site Not yet recruiting
Ulsan, Korea, Republic of
Latvia
Research Site Withdrawn
Ogre, Latvia
Research Site Withdrawn
Riga, Latvia
Research Site Withdrawn
Sigulda, Latvia
Research Site Withdrawn
Ventspils, Latvia
Lithuania
Research Site Recruiting
Alytus, Lithuania
Research Site Recruiting
Kaunas, Lithuania
Research Site Not yet recruiting
Kaunas, Lithuania
Research Site Recruiting
Klaipeda, Lithuania
Research Site Recruiting
Panevezys, Lithuania
Research Site Not yet recruiting
Prienai, Lithuania
Research Site Not yet recruiting
Siauliai, Lithuania
Research Site Recruiting
Siauliai, Lithuania
Research Site Recruiting
Vilnius, Lithuania
Mexico
Research Site Not yet recruiting
Acapulco, Mexico
Research Site Recruiting
Chihuahua, Mexico
Research Site Recruiting
Cuautitlan Izcalli, Mexico
Research Site Recruiting
Culiacan, Mexico
Research Site Not yet recruiting
Durango, Mexico
Research Site Not yet recruiting
Guadalajara, Mexico
Research Site Recruiting
Guadalajara, Mexico
Research Site Recruiting
Merida, Mexico
Research Site Not yet recruiting
Meridas, Mexico
Research Site Not yet recruiting
Mexico, Mexico
Research Site Recruiting
Mexico, Mexico
Research Site Not yet recruiting
Monclova, Mexico
Research Site Recruiting
Monterrey, Mexico
Research Site Not yet recruiting
Monterrey, Mexico
Research Site Not yet recruiting
México, Mexico
Research Site Not yet recruiting
Querétaro, Mexico
Research Site Not yet recruiting
San Luis Potosi, Mexico
Research Site Not yet recruiting
Torreon, Mexico
Research Site Not yet recruiting
Veracruz, Mexico
Research Site Not yet recruiting
Xalapa, Mexico
Research Site Recruiting
Zapopan, Jalisco, Mexico
Netherlands
Research Site Recruiting
Almelo, Netherlands
Research Site Recruiting
Almere, Netherlands
Research Site Withdrawn
Amersfoort, Netherlands
Research Site Recruiting
Amsterdam, Netherlands
Research Site Withdrawn
Amsterdam, Netherlands
Research Site Recruiting
Apeldoorn, Netherlands
Research Site Recruiting
Arnhem, Netherlands
Research Site Recruiting
Beek, Netherlands
Research Site Withdrawn
Beverwijk, Netherlands
Research Site Withdrawn
Breda, Netherlands
Research Site Recruiting
Delft, Netherlands
Research Site Withdrawn
Deventer, Netherlands
Research Site Not yet recruiting
EDE, Netherlands
Research Site Recruiting
Eindhoven, Netherlands
Research Site Not yet recruiting
Groningen, Netherlands
Research Site Withdrawn
Groningen, Netherlands
Research Site Recruiting
Harderwijk, Netherlands
Research Site Recruiting
Heerlen, Netherlands
Research Site Recruiting
Hilversum, Netherlands
Research Site Recruiting
Hoofddorp, Netherlands
Research Site Recruiting
Hoogeveen, Netherlands
Research Site Recruiting
Hoorn, Netherlands
Research Site Recruiting
Maastricht, Netherlands
Research Site Recruiting
Nijmegen, Netherlands
Research Site Recruiting
Rotterdam, Netherlands
Research Site Suspended
Rotterdam, Netherlands
Research Site Recruiting
Schiedam, Netherlands
Research Site Recruiting
Sneek, Netherlands
Research Site Not yet recruiting
Tilburg, Netherlands
Research Site Recruiting
Utrecht, Netherlands
Research Site Suspended
Utrecht, Netherlands
Research Site Withdrawn
Velp, Netherlands
Research Site Recruiting
Venlo, Netherlands
Research Site Withdrawn
Zoetermeer, Netherlands
Research Site Recruiting
Zoetermeer, Netherlands
Research Site Recruiting
Zwijndrecht, Netherlands
Research Site Not yet recruiting
Zwijndrecht, Netherlands
New Zealand
Research Site Recruiting
Auckland, New Zealand
Research Site Recruiting
Christchurch, New Zealand
Research Site Recruiting
Rotorua, New Zealand
Research Site Not yet recruiting
Tauranga, New Zealand
Research Site Recruiting
Wellington, New Zealand
Poland
Research Site Recruiting
Białystok, Poland
Research Site Recruiting
Chorzów, Poland
Research Site Recruiting
Elbląg, Poland
Research Site Recruiting
Gdańsk, Poland
Research Site Recruiting
Gdynia, Poland
Research Site Withdrawn
Gliwice, Poland
Research Site Recruiting
Katowice, Poland
Research Site Suspended
Krakow, Poland
Research Site Not yet recruiting
Krakow, Poland
Research Site Recruiting
Kraków, Poland
Research Site Recruiting
Lodz, Poland
Research Site Recruiting
Lublin, Poland
Research Site Not yet recruiting
Lublin, Poland
Research Site Recruiting
Oświęcim, Poland
Research Site Recruiting
Parczew, Poland
Research Site Recruiting
Piaseczno, Poland
Research Site Withdrawn
Poznan, Poland
Research Site Recruiting
Poznań, Poland
Research Site Recruiting
Puławy, Poland
Research Site Recruiting
Płock, Poland
Research Site Recruiting
Ruda Śląska, Poland
Research Site Recruiting
Rzeszów, Poland
Research Site Recruiting
Sobótka, Poland
Research Site Recruiting
Sopot, Poland
Research Site Recruiting
Staszów, Poland
Research Site Recruiting
Toruń, Poland
Research Site Recruiting
Warszawa, Poland
Research Site Recruiting
Wrocław, Poland
Research Site Recruiting
Zamość, Poland
Research Site Recruiting
Zgierz, Poland
Research Site Recruiting
Łódź, Poland
Russian Federation
Research Site Recruiting
Barnaul, Russian Federation
Research Site Not yet recruiting
Barnaul, Russian Federation
Research Site Recruiting
Kemerovo, Russian Federation
Research Site Not yet recruiting
Kemerovo, Russian Federation
Research Site Withdrawn
Moscow, Russian Federation
Research Site Recruiting
Moscow, Russian Federation
Research Site Suspended
Moscow, Russian Federation
Research Site Not yet recruiting
Nizhniy Novgorod, Russian Federation
Research Site Recruiting
Novosibirsk, Russian Federation
Research Site Not yet recruiting
Novosibirsk, Russian Federation
Research Site Recruiting
Omsk, Russian Federation
Research Site Recruiting
Orenburg, Russian Federation
Research Site Recruiting
Perm, Russian Federation
Research Site Not yet recruiting
Rostov-na-Donu, Russian Federation
Research Site Not yet recruiting
Ryazan, Russian Federation
Research Site Recruiting
Saint Petersburg, Russian Federation
Research Site Recruiting
Saint-Petersburg, Russian Federation
Research Site Recruiting
St-Petersburg, Russian Federation
Research Site Recruiting
St. Petersburg, Russian Federation
Research Site Not yet recruiting
St. Petersburg, Russian Federation
Research Site Recruiting
Tomsk, Russian Federation
Research Site Not yet recruiting
Tomsk, Russian Federation
Research Site Not yet recruiting
Yaroslavl, Russian Federation
Research Site Recruiting
Yaroslavl, Russian Federation
South Africa
Research Site Recruiting
Bloemfontein, South Africa
Research Site Not yet recruiting
Brandfort, South Africa
Research Site Recruiting
Breyton, South Africa
Research Site Recruiting
Cape Town, South Africa
Research Site Withdrawn
Cape Town, South Africa
Research Site Recruiting
Centurion, South Africa
Research Site Recruiting
Durban, South Africa
Research Site Not yet recruiting
Durban, South Africa
Research Site Recruiting
George, South Africa
Research Site Not yet recruiting
Johannesburg, South Africa
Research Site Withdrawn
Johannesburg, South Africa
Research Site Recruiting
Johannesburg, South Africa
Research Site Recruiting
Krugersdorp, South Africa
Research Site Recruiting
Kuilsrivier, South Africa
Research Site Recruiting
Mamelodi East, South Africa
Research Site Recruiting
Middelburg, South Africa
Research Site Recruiting
Moloto, South Africa
Research Site Recruiting
Paarl, South Africa
Research Site Recruiting
Port Elizabeth, South Africa
Research Site Recruiting
Potchefstroom, South Africa
Research Site Not yet recruiting
Pretoria, South Africa
Research Site Recruiting
Pretoria, South Africa
Research Site Suspended
Pretoria, South Africa
Research Site Withdrawn
Richards Bay, South Africa
Research Site Recruiting
Somerset West, South Africa
Research Site Recruiting
Soweto, South Africa
Research Site Recruiting
Stanger, South Africa
Research Site Not yet recruiting
Verulam, South Africa
Research Site Recruiting
Worcester, South Africa
Taiwan
Research Site Recruiting
Kaohsiung, Taiwan
Research Site Recruiting
Taipei, Taiwan
Ukraine
Research Site Withdrawn
Alupka, Crimea, Ukraine
Research Site Recruiting
Cherkasy, Ukraine
Research Site Not yet recruiting
Chernivtsi, Ukraine
Research Site Not yet recruiting
Dnipropetrovsk, Ukraine
Research Site Not yet recruiting
Ivano-Frankivsk, Ukraine
Research Site Recruiting
Ivano-Frankivsk, Ukraine
Research Site Recruiting
Kharkiv, Ukraine
Research Site Not yet recruiting
Kiev, Ukraine
Research Site Withdrawn
Kiev, Ukraine
Research Site Recruiting
Kiev, Ukraine
Research Site Recruiting
Kyiv, Ukraine
Research Site Not yet recruiting
Kyiv, Ukraine
Research Site Recruiting
Lutsk, Ukraine
Research Site Not yet recruiting
Lviv, Ukraine
Research Site Recruiting
Lviv, Ukraine
Research Site Suspended
Lviv, Ukraine
Research Site Recruiting
Mykolayiv, Ukraine
Research Site Recruiting
Odesa, Ukraine
Research Site Not yet recruiting
Odessa, Ukraine
Research Site Not yet recruiting
Poltava, Ukraine
Research Site Withdrawn
Simferopol, Ukraine
Research Site Not yet recruiting
Uzhgorod, Ukraine
Research Site Not yet recruiting
Vinnytsia, Ukraine
Research Site Recruiting
Vinnytsia, Ukraine
Research Site Suspended
Zaporizhzhia, Ukraine
Research Site Recruiting
Zaporizhzhia, Ukraine
Research Site Not yet recruiting
Zaporizhzhia, Ukraine
Research Site Not yet recruiting
Zhytomyr, Ukraine
United Kingdom
Research Site Recruiting
Airdrie, United Kingdom
Research Site Not yet recruiting
Atherstone, United Kingdom
Research Site Withdrawn
Barnet, United Kingdom
Research Site Suspended
Basildon, United Kingdom
Research Site Not yet recruiting
Bexhill-on-Sea, United Kingdom
Research Site Recruiting
Bournemouth, United Kingdom
Research Site Recruiting
Cardiff, United Kingdom
Research Site Recruiting
Chelmsford, United Kingdom
Research Site Recruiting
Chorley, United Kingdom
Research Site Withdrawn
Chorley, United Kingdom
Research Site Withdrawn
Dundee, United Kingdom
Research Site Recruiting
East Kilbride, United Kingdom
Research Site Recruiting
Edgbaston, United Kingdom
Research Site Recruiting
Edinburgh, United Kingdom
Research Site Recruiting
Exeter, United Kingdom
Research Site Recruiting
Glasgow, United Kingdom
Research Site Recruiting
Hexham, United Kingdom
Research Site Not yet recruiting
Leamington Spa, United Kingdom
Research Site Not yet recruiting
Leeds, United Kingdom
Research Site Not yet recruiting
Leicester, United Kingdom
Research Site Recruiting
Liverpool, United Kingdom
Research Site Recruiting
London, United Kingdom
Research Site Not yet recruiting
London, United Kingdom
Research Site Recruiting
Manchester, United Kingdom
Research Site Recruiting
Reading, United Kingdom
Research Site Recruiting
Romford, United Kingdom
Research Site Withdrawn
Salford, United Kingdom
Research Site Recruiting
Stevenage, United Kingdom
Research Site Recruiting
Swansea, United Kingdom
Research Site Not yet recruiting
Torpoint, United Kingdom
Research Site Recruiting
Torquay, United Kingdom
Research Site Withdrawn
Truro, United Kingdom
Sponsors and Collaborators
AstraZeneca
Cleveland Clinic Coordinating Center for Clinical Research (C5R)
Quintiles, Inc.
Investigators
Principal Investigator: Steven Nissen, MD The Cleveland Clinic
Principal Investigator: Michael Lincoff, MD The Cleveland Clinic
Principal Investigator: Stephen Nicholls, MD Adelaide Clinical Research
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02104817     History of Changes
Other Study ID Numbers: D5881C00004  2014-001069-28 
Study First Received: April 2, 2014
Last Updated: July 6, 2016
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by AstraZeneca:
omega-3 carboxylic acid

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertriglyceridemia
Atherosclerosis
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 27, 2016