A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
14. januar 2019 opdateret af: Alkermes, Inc.
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia
The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
623
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Burgas, Bulgarien
- Alkermes Investigational Site
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Kazanlak, Bulgarien
- Alkermes Investigational Site
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Novi Iskar, Bulgarien
- Alkermes Investigational Site
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Pazardzhik, Bulgarien
- Alkermes Investigational Site
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Pleven, Bulgarien
- Alkermes Investigational Site
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Plovdiv, Bulgarien
- Alkermes Investigational Site
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Radnevo, Bulgarien
- Alkermes Investigational Site
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Ruse, Bulgarien
- Alkermes Investigational Site
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Sofia, Bulgarien
- Alkermes Investigational Site
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Stara Zagora, Bulgarien
- Alkermes Investigational Site
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Targovishte, Bulgarien
- Alkermes Investigational Site
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Veliko Tarnovo, Bulgarien
- Alkermes Investigational Site
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Vratsa, Bulgarien
- Alkermes Investigational Site
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Lipetsk, Den Russiske Føderation
- Alkermes Investigational Site
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Moscow, Den Russiske Føderation
- Alkermes Investigational Site
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Nizhniy Novgorod, Den Russiske Føderation
- Alkermes Investigational Site
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Rostov-on-Don, Den Russiske Føderation
- Alkermes Investigational Site
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Samara, Den Russiske Føderation
- Alkermes Investigational Site
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Saratov, Den Russiske Føderation
- Alkermes Investigational Site
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St. Petersburg, Den Russiske Føderation
- Alkermes Investigational Site
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Stavropol, Den Russiske Føderation
- Alkermes Investigational Site
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Voronezh, Den Russiske Føderation
- Alkermes Investigational Site
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Yaroslavl, Den Russiske Føderation
- Alkermes Investigational Site
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Gatchinckiy
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Nikol'skoye, Gatchinckiy, Den Russiske Føderation
- Alkermes Investigational Site
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Orenburg
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Staritsa, Orenburg, Den Russiske Føderation
- Alkermes Investigational Site
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Primorsky
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Talagi, Primorsky, Den Russiske Føderation
- Alkermes Investigational Site
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Sergievo-Posadskiy
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Khotkovo, Sergievo-Posadskiy, Den Russiske Føderation
- Alkermes Investigational Site
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Cebu City, Filippinerne
- Alkermes Investigational Site
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Iloilo City, Filippinerne
- Alkermes Investigational Site
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Mandaluyong City, Filippinerne
- Alkermes Investigational Site
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Manila, Filippinerne
- Alkermes Investigational Site
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Pasig City, Filippinerne
- Alkermes Investigational Site
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Bataan
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Mariveles, Bataan, Filippinerne
- Alkermes Investigational Site
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72201
- Alkermes Investigational Site
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Little Rock, Arkansas, Forenede Stater, 72211
- Alkermes Investigational Site
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Springdale, Arkansas, Forenede Stater, 72764
- Alkermes Investigational Site
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California
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Cerritos, California, Forenede Stater, 90703
- Alkermes Investigational Site
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Garden Grove, California, Forenede Stater, 92845
- Alkermes Investigational Site
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La Habra, California, Forenede Stater, 90631
- Alkermes Investigational Site
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Oakland, California, Forenede Stater, 94612
- Alkermes Investigational Site
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Oceanside, California, Forenede Stater, 92056
- Alkermes Investigational Site
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Orange, California, Forenede Stater, 92868
- Alkermes Investigational Site
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San Diego, California, Forenede Stater, 92123
- Alkermes Investigational Site
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20016
- Alkermes Investigational Site
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Alkermes Investigational Site
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Leesburg, Florida, Forenede Stater, 34748
- Alkermes Investigational Site
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Georgia
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Atlanta, Georgia, Forenede Stater, 30308
- Alkermes Investigational Site
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Illinois
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Chicago, Illinois, Forenede Stater, 60640
- Alkermes Investigational Site
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Hoffman Estates, Illinois, Forenede Stater, 60169
- Alkermes Investigational Site
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Kansas
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Overland Park, Kansas, Forenede Stater, 66212
- Alkermes Investigational Site
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Maryland
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Rockville, Maryland, Forenede Stater, 20850
- Alkermes Investigational Site
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Missouri
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Creve Coeur, Missouri, Forenede Stater, 63141
- Alkermes Investigational Site
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Saint Louis, Missouri, Forenede Stater, 63118
- Alkermes Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19139
- Alkermes Investigational Site
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29407
- Alkermes Investigational Site
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Texas
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Austin, Texas, Forenede Stater, 78731
- Alkermes Investigational Site
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Austin, Texas, Forenede Stater, 78754
- Alkermes Investigational Site
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Dallas, Texas, Forenede Stater, 75231
- Alkermes Investigational Site
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Dallas, Texas, Forenede Stater, 75243
- Alkermes Investigational Site
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Jeju-si, Korea, Republikken
- Alkermes Investigational Site
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Jeollanam-do, Korea, Republikken
- Alkermes Investigational Site
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Seoul, Korea, Republikken
- Alkermes Investigational Site
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Cheras, Malaysia
- Alkermes Investigational Site
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Johor Bahru, Malaysia
- Alkermes Investigational Site
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Kuala Lumpur, Malaysia
- Alkermes Investigational Site
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Kuching, Malaysia
- Alkermes Investigational Site
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Bucharest, Rumænien, 030455
- Alkermes Investigational Site
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Bucharest, Rumænien
- Alkermes Investigational Site
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Craiova, Rumænien
- Alkermes Investigational Site
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Iasi, Rumænien
- Alkermes Investigational Site
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Targu Mures, Rumænien
- Alkermes Investigational Site
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Bihor
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Oradea, Bihor, Rumænien
- Alkermes Investigational Site
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Chernigiv, Ukraine
- Alkermes Investigational Site
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Donetsk, Ukraine
- Alkermes Investigational Site
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Kharkiv, Ukraine
- Alkermes Investigational Site
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Kyiv, Ukraine
- Alkermes Investigational Site
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Lugansk, Ukraine
- Alkermes Investigational Site
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Lviv, Ukraine
- Alkermes Investigational Site
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Poltava, Ukraine
- Alkermes Investigational Site
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Simferopol, Ukraine
- Alkermes Investigational Site
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Ternopil, Ukraine
- Alkermes Investigational Site
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Uzhgorod, Ukraine
- Alkermes Investigational Site
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Vinnytsya, Ukraine
- Alkermes Investigational Site
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Kherson
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Stepanovka, Kherson, Ukraine
- Alkermes Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosis of schizophrenia according to DSM-IV-TR criteria
- Has been able to achieve outpatient status for more than 3 months in the past year
- Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
- Resides in a stable living situation
- Willing and able to be confined to an inpatient study unit for 2 weeks or longer
Exclusion Criteria:
- History of poor or inadequate clinical response to treatment with aripiprazole
- History of treatment resistance
- Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)
- Diagnosis of current substance dependence (including alcohol)
- Pregnant, lactating, or breastfeeding
- Receipt of any antipsychotic medication by IM injection within 60 days before Screening
- Current involuntary hospitalization or incarceration
- Hospitalized for more than 30 days during the 90 days before Screening
Additional inclusion/exclusion criteria may apply.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: Placebo
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Placebo for IM injection, given monthly
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Eksperimentel: ALKS 9072
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Intramuscular (IM) injection, 441 mg or 882 mg given monthly
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score
Tidsramme: Data collected from baseline to day 85
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The PANSS scale contains 30 questions, each containing an answer range of 1-7.
A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.
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Data collected from baseline to day 85
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
Tidsramme: 85 Days
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The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study.
Results indicate participants evaluated at one of the following categories: "1: very much improved"; "2: much improved"; "3: minimally improved"; "4: no change"; "5: minimally worse"; "6: much worse"; or "7: very much worse".
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85 Days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Targum SD, Risinger R, Du Y, Pendergrass JC, Jamal HH, Silverman BL. Effect of patient age on treatment response in a study of the acute exacerbation of psychosis in schizophrenia. Schizophr Res. 2017 Jan;179:64-69. doi: 10.1016/j.schres.2016.09.034. Epub 2016 Oct 1.
- Nasrallah HA, Newcomer JW, Risinger R, Du Y, Zummo J, Bose A, Stankovic S, Silverman BL, Ehrich EW. Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles and Related Safety Considerations Among Patients With Acute Schizophrenia. J Clin Psychiatry. 2016 Nov;77(11):1519-1525. doi: 10.4088/JCP.15m10467.
- Citrome L, Du Y, Risinger R, Stankovic S, Claxton A, Zummo J, Bose A, Silverman BL, Ehrich EW. Effect of aripiprazole lauroxil on agitation and hostility in patients with schizophrenia. Int Clin Psychopharmacol. 2016 Mar;31(2):69-75. doi: 10.1097/YIC.0000000000000106.
- Meltzer HY, Risinger R, Nasrallah HA, Du Y, Zummo J, Corey L, Bose A, Stankovic S, Silverman BL, Ehrich EW. A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia. J Clin Psychiatry. 2015 Aug;76(8):1085-90. doi: 10.4088/JCP.14m09741.
- Potkin SG, Risinger R, Du Y, Zummo J, Bose A, Silverman B, Stankovic S, Ehrich E. Efficacy and safety of aripiprazole lauroxil in schizophrenic patients presenting with severe psychotic symptoms during an acute exacerbation. Schizophr Res. 2017 Dec;190:115-120. doi: 10.1016/j.schres.2017.03.003. Epub 2017 Mar 23.
- Cameron C, Zummo J, Desai DN, Drake C, Hutton B, Kotb A, Weiden PJ. Aripiprazole Lauroxil Compared with Paliperidone Palmitate in Patients with Schizophrenia: An Indirect Treatment Comparison. Value Health. 2017 Jul-Aug;20(7):876-885. doi: 10.1016/j.jval.2017.03.010. Epub 2017 May 9.
- Citrome L, Risinger R, Cutler AJ, Du Y, Zummo J, Nasrallah HA, Silverman BL. Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale-supportive analyses from a Phase 3 study. CNS Spectr. 2018 Aug;23(4):284-290. doi: 10.1017/S1092852917000396. Epub 2017 Jun 19.
- Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691.
- Cameron C, Zummo J, Desai D, Drake C, Hutton B, Kotb A, Weiden PJ. Efficacy and safety of aripiprazole lauroxil once-monthly versus aripiprazole once-monthly long-acting injectable formulations in patients with acute symptoms of schizophrenia: an indirect comparison of two double-blind placebo-controlled studies. Curr Med Res Opin. 2018 Apr;34(4):725-733. doi: 10.1080/03007995.2017.1410471. Epub 2018 Jan 10.
- McEvoy JP, Risinger R, Mykhnyak S, Du Y, Liu CC, Stanford AD, Weiden PJ. Durability of Therapeutic Response With Long-Term Aripiprazole Lauroxil Treatment Following Successful Resolution of an Acute Episode of Schizophrenia. J Clin Psychiatry. 2017 Sep-Oct;78(8):1103-1109. doi: 10.4088/JCP.17m11625.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2011
Primær færdiggørelse (Faktiske)
1. januar 2014
Studieafslutning (Faktiske)
1. marts 2014
Datoer for studieregistrering
Først indsendt
8. november 2011
Først indsendt, der opfyldte QC-kriterier
8. november 2011
Først opslået (Skøn)
10. november 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. januar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. januar 2019
Sidst verificeret
1. januar 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ALK9072-003
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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