A Long-Term Safety Study of ALKS 5461

NCT02141399 | Completed Phase 3 Results

• 1 other identifier: ALK5461-208
• Study Type: interventional
• Target: 1,485
• Locations: 8 countries
• Sites: 158

Brief Summary

This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs)

  Up to 56 weeks

Study Arms (1)

ALKS 5461

EXPERIMENTAL

Drug: ALKS 5461

Interventions

ALKS 5461 DRUG

Sublingual tablet, taken daily

ALKS 5461

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree to use an approved method of contraception for the duration of the study
• Have the potential to safely benefit from the administration of ALKS 5461
• Have a diagnosis of major depressive disorder (MDD)
• Additional criteria may apply

You may not qualify if:

• Have a positive test for drugs of abuse
• Currently pregnant or breastfeeding
• Have a current primary Axis-I disorder other than MDD
• Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
• Have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime
• Have attempted suicide within the past 2 years
• Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
• Have had a significant blood loss or blood donation within the past 60 days
• Additional criteria may apply

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (158)

Alkermes Investigational Site

Birmingham, Alabama, 35226, United States

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Alkermes Investigational Site

Birmingham, Alabama, 35294, United States

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Tucson, Arizona, 85712, United States

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Little Rock, Arkansas, 72211, United States

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Bellflower, California, 90706, United States

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Beverly Hills, California, 90210, United States

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Carson, California, 90746, United States

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Garden Grove, California, 92845, United States

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Glendale, California, 91206, United States

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Los Alamitos, California, 90720, United States

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Los Angeles, California, 90024, United States

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National City, California, 91950, United States

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Oakland, California, 94612, United States

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Oceanside, California, 92056, United States

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Orange, California, 92868, United States

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Pico Rivera, California, 90660, United States

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Redlands, California, 92374, United States

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San Gabriel, California, 91776, United States

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Sherman Oaks, California, 91403, United States

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Temecula, California, 92591, United States

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Torrance, California, 90502, United States

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Upland, California, 91786, United States

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Colorado Springs, Colorado, 80910, United States

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Denver, Colorado, 80209, United States

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Hartford, Connecticut, 06106, United States

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Norwich, Connecticut, 06360, United States

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Bradenton, Florida, 34201, United States

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Coral Springs, Florida, 33067, United States

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Fort Myers, Florida, 33912, United States

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Gainesville, Florida, 32607, United States

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Hallandale, Florida, 33009, United States

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Hialeah, Florida, 33016, United States

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Jacksonville, Florida, 32256, United States

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Lauderhill, Florida, 33319, United States

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Maitland, Florida, 32751, United States

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Melbourne, Florida, 32901, United States

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North Miami, Florida, 33161, United States

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Oakland Park, Florida, 33334, United States

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Orlando, Florida, 32801, United States

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Tampa, Florida, 33613, United States

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The Villages, Florida, 32162, United States

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West Palm Beach, Florida, 33407, United States

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Winter Haven, Florida, 33880, United States

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Alpharetta, Georgia, 30005, United States

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Atlanta, Georgia, 30308, United States

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Decatur, Georgia, 30030, United States

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Smyrna, Georgia, 30080, United States

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Chicago, Illinois, 60634, United States

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Chicago, Illinois, 60640, United States

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Deerfield, Illinois, 60015, United States

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Hoffman Estates, Illinois, 60169, United States

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Joliet, Illinois, 60435, United States

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Oak Brook, Illinois, 60523, United States

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Skokie, Illinois, 60076, United States

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Indianapolis, Indiana, 46260, United States

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Lafayette, Indiana, 47905, United States

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Newburgh, Indiana, 47630, United States

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Valparaiso, Indiana, 46383, United States

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Edgewood, Kentucky, 41017, United States

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Owensboro, Kentucky, 42301, United States

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Baltimore, Maryland, 21204, United States

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Baltimore, Maryland, 21208, United States

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Washington D.C., Maryland, 20016, United States

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Belmont, Massachusetts, 02478, United States

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Brockton, Massachusetts, 02301, United States

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Watertown, Massachusetts, 02472, United States

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Worcester, Massachusetts, 01655, United States

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Flowood, Mississippi, 39232, United States

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O'Fallon, Missouri, 63368, United States

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Saint Charles, Missouri, 63304, United States

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St Louis, Missouri, 63109, United States

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St Louis, Missouri, 63141, United States

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Berlin, New Jersey, 80091, United States

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Cherry Hill, New Jersey, 08002, United States

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Princeton, New Jersey, 08540, United States

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Albuquerque, New Mexico, 87109, United States

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Brooklyn, New York, 11241, United States

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Jamaica, New York, 11432, United States

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Mount Kisco, New York, 10549, United States

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New York, New York, 10019, United States

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New York, New York, 10023, United States

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New York, New York, 10029, United States

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New York, New York, 10128, United States

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New York, New York, 10168, United States

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Staten Island, New York, 10305, United States

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Staten Island, New York, 10312, United States

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Charlotte, North Carolina, 28204, United States

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High Point, North Carolina, 27265, United States

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Beachwood, Ohio, 44122, United States

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Canton, Ohio, 44718, United States

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Cincinnati, Ohio, 45215, United States

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Cincinnati, Ohio, 45227, United States

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Dayton, Ohio, 45417, United States

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Mason, Ohio, 45040, United States

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Middleburg Heights, Ohio, 44130, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73112, United States

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Portland, Oregon, 97210, United States

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Portland, Oregon, 97214, United States

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Salem, Oregon, 97301, United States

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Allentown, Pennsylvania, 18104, United States

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Media, Pennsylvania, 19063, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Lincoln, Rhode Island, 02865, United States

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Charleston, South Carolina, 29407, United States

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Memphis, Tennessee, 38119, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75390, United States

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DeSoto, Texas, 75115, United States

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Houston, Texas, 77081, United States

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Houston, Texas, 77098, United States

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San Antonio, Texas, 78229, United States

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Sugar Land, Texas, 77478, United States

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Wichita Falls, Texas, 76309, United States

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Clinton, Utah, 84015, United States

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Woodstock, Vermont, 05091, United States

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Bellevue, Washington, 98007, United States

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Seattle, Washington, 98104, United States

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Spokane, Washington, 99204, United States

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Middleton, Wisconsin, 53562, United States

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Waukesha, Wisconsin, 53188, United States

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Towong, Queensland, 4066, Australia

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Frankston, Victoria, 3199, Australia

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Melbourne, Victoria, 3004, Australia

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Burgas, 8001, Bulgaria

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Kazanlak, 6100, Bulgaria

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Sofia, 1113, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1632, Bulgaria

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Varna, 9020, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Vratsa, 3000, Bulgaria

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Penticton, British Columbia, V2A 4M4, Canada

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Halifax, Nova Scotia, B3S 1L8, Canada

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Gatineau, Quebec, J8T 8JL, Canada

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Québec, G3K 2P8, Canada

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Oranienburg, Brandenburg, 16515, Germany

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Achim, 28832, Germany

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Berlin, 10245, Germany

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Berlin, 10365, Germany

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Berlin, 10629, Germany

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Ellwangen, 73479, Germany

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Freiburg im Breisgau, 79104, Germany

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Hanover, 30159, Germany

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Mainz, 55131, Germany

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Schwerin, 19053, Germany

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Stralsund, 18439, Germany

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Budapest, 1053, Hungary

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Budapest, 1135, Hungary

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Budapest, 1137, Hungary

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Bialystok, 15-879, Poland

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Alkermes Investigational Site

Gdansk, 80-438, Poland

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Alkermes Investigational Site

Gdansk, 80-546, Poland

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Alkermes Investigational Site

Gorlice, 38-300, Poland

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Alkermes Investigational Site

San Juan, 00918, Puerto Rico

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Alkermes Investigational Site

San Juan, 00926, Puerto Rico

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MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

ALKS 5461

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Eva Stroynowski
• Organization: Alkermes

Eva.Stroynowski@alkermes.com

781-609-7000

Study Officials

• Sanjeev Pathak, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 19, 2014
• Study Start: May 1, 2014
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: December 14, 2018
• Results First Posted: December 14, 2018

Record last verified: 2018-11

Locations

CA (4); PL (4); HU (3); BU (8); AU (3); DE (11); US (123); PR (2)