Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: August 23, 2019

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CLINICAL TRIALS PROFILE FOR VIVITROL

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Clinical Trials for VIVITROL

Trial ID Title Status Sponsor Phase Summary
NCT00156923 ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults Completed Alkermes, Inc. Phase 3 This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).
NCT00156936 ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997]) Terminated Alkermes, Inc. Phase 3 This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®). Planned treatment duration was up to 3 years. Alkermes terminated the study for business purposes in December 2006. The median duration of treatment among all subjects in this extension study was 43 weeks.
NCT00338962 Naltrexone & SSRI in Alcoholics With Depression/PTSD Completed Yale University Phase 3 The purpose of this study is to evaluate the efficacy of naltrexone in combination with an SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression. We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in alcohol consumption than that seen with treatment with SSRI alone, or with a combination of another class of antidepressant and naltrexone. We also hypothesize that SSRI will be effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.
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Clinical Trial Conditions for VIVITROL

Condition Name

Condition Name for VIVITROL
Intervention Trials
Alcohol Dependence 11
Opiate Dependence 10
Opioid Dependence 7
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Condition MeSH

Condition MeSH for VIVITROL
Intervention Trials
Alcoholism 17
Opioid-Related Disorders 17
Disease 7
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Clinical Trial Locations for VIVITROL

Trials by Country

Trials by Country for VIVITROL
Location Trials
United States 89
Norway 5
Russian Federation 2
Netherlands 1
Lithuania 1
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Trials by US State

Trials by US State for VIVITROL
Location Trials
New York 21
California 9
Maryland 6
Connecticut 5
Texas 5
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Clinical Trial Progress for VIVITROL

Clinical Trial Phase

Clinical Trial Phase for VIVITROL
Clinical Trial Phase Trials
Phase 4 14
Phase 3 20
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for VIVITROL
Clinical Trial Phase Trials
Completed 35
Recruiting 13
Active, not recruiting 6
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Clinical Trial Sponsors for VIVITROL

Sponsor Name

Sponsor Name for VIVITROL
Sponsor Trials
Alkermes, Inc. 24
National Institute on Drug Abuse (NIDA) 22
New York State Psychiatric Institute 11
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Sponsor Type

Sponsor Type for VIVITROL
Sponsor Trials
Other 69
Industry 31
NIH 28
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Johnson and Johnson

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