Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)

9. september 2026 oppdatert av: Eli Lilly and Company

Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial

The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity. Participation in the study will last about 104 weeks.

Participants who have completed the primary 104-week PW02 study (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Telefonnummer: 1-317-615-4559
  • E-post: LillyTrials@Lilly.com

Studer Kontakt Backup

Studiesteder

  • Belgia
      • Brussels, Belgia, 1200
        • Cliniques Universitaires Saint-Luc - PPDS
        • Hovedetterforsker:
          • Philippe Lysy
      • Jette, Belgia, 1090
        • UZ Brussel
        • Hovedetterforsker:
          • Inge Gies
      • Leuven, Belgia, 3000
        • UZ Leuven
        • Hovedetterforsker:
          • Kristina Casteels
  • Forente stater
    • Arizona
      • Tucson, Arizona, Forente stater, 85721
        • University of Arizona
        • Hovedetterforsker:
          • Sunil Sinha
        • Ta kontakt med:
          • Telefonnummer: 520-626-8000
    • California
      • Loma Linda, California, Forente stater, 92354
        • Loma Linda University School of Medicine
        • Hovedetterforsker:
          • Prashanth Porayette
      • Los Angeles, California, Forente stater, 90095
        • UCLA Mattel Children's Hospital
        • Hovedetterforsker:
          • Vibha Singhal
      • Los Angeles, California, Forente stater, 90027
        • Childrens Hospital of Los Angeles
        • Hovedetterforsker:
          • Alaina Vidmar
      • Orange, California, Forente stater, 92868
        • Children's Hospital of Orange County
        • Hovedetterforsker:
          • Amruta Thakkar
        • Ta kontakt med:
          • Telefonnummer: 714-509-8824
      • Oxnard, California, Forente stater, 93003-5314
        • Carey Chronis MD Pediatric, Infant and Adolescent Medicine
        • Hovedetterforsker:
          • Carey Chronis
        • Ta kontakt med:
          • Telefonnummer: 805-483-1185 x.947
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80920-7843
        • Children's Hospital Colorado
        • Hovedetterforsker:
          • Melanie Cree
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06504
        • Yale New Haven Children's Hospital
        • Hovedetterforsker:
          • Ania Jastreboff
    • Florida
      • Gainesville, Florida, Forente stater, 32610-3003
        • William A. Shands Hospital at the University of Florida
        • Hovedetterforsker:
          • Angelina Bernier
      • Orlando, Florida, Forente stater, 32827
        • Nemours Children's Health
        • Hovedetterforsker:
          • Miles Yu
      • Orlando, Florida, Forente stater, 32803
        • Florida Hospital- Center for Pediatric Research
        • Hovedetterforsker:
          • Konda Reddy
        • Ta kontakt med:
          • Telefonnummer: 407-303-9826
      • Saint Petersburgh, Florida, Forente stater, 33701
        • All Childrens Hospital
        • Hovedetterforsker:
          • Raquel Hernandez
    • Georgia
      • Atlanta, Georgia, Forente stater, 30329
        • Children's Healthcare of Atlanta - Center for Advanced Pediatrics
        • Hovedetterforsker:
          • Daniel Hsia
        • Ta kontakt med:
          • Telefonnummer: 404-785-5686
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • University of Illinois at Chicago
        • Hovedetterforsker:
          • Shruti Sakhuja
      • Chicago, Illinois, Forente stater, 60611
        • Ann and Robert H Lurie Children's Hospital of Chicago
        • Hovedetterforsker:
          • Justin Ryder
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Riley Hospital for Children
        • Hovedetterforsker:
          • Sara Naramore
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40202
        • Norton Children's Endocrinology
        • Hovedetterforsker:
          • Sara Watson
        • Ta kontakt med:
          • Telefonnummer: 502-588-2590
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Johns Hopkins Children's Center
        • Hovedetterforsker:
          • Gihan Naguib
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Boston Children's Hospital
        • Hovedetterforsker:
          • Amy Fleischman
    • Michigan
      • Grand Rapids, Michigan, Forente stater, 49503-2560
        • Helen Devos Childrens' Hospital - PIN
        • Hovedetterforsker:
          • Miriam Vos
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55454
        • University of Minnesota Masonic Children's Hospital
        • Hovedetterforsker:
          • Claudia Fox
        • Ta kontakt med:
          • Telefonnummer: (612) 625-3623
      • Rochester, Minnesota, Forente stater, 55905-0001
        • Mayo Clinic - PIN
        • Hovedetterforsker:
          • Seema Kumar
        • Ta kontakt med:
          • Telefonnummer: (507) 538-7804
      • Saint Paul, Minnesota, Forente stater, 55102-3354
        • Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center
        • Hovedetterforsker:
          • Jennifer Abuzzahab
        • Ta kontakt med:
          • Telefonnummer: 651-220-5730
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68114
        • Children's Hospital & Medical Center
        • Hovedetterforsker:
          • Alvaro Flores Lopez
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Hackensack University Medical Center
        • Hovedetterforsker:
          • Steven Ghanny
    • New York
      • Buffalo, New York, Forente stater, 14203
        • UBMD Pediatrics
        • Hovedetterforsker:
          • Lucy Mastrandrea
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27514
        • UNC Children's Hospital
        • Hovedetterforsker:
          • Nina Jain
      • Durham, North Carolina, Forente stater, 27704-2102
        • Duke Children's Primary Care
        • Hovedetterforsker:
          • Sarah Armstrong
      • Morehead City, North Carolina, Forente stater, 28557
        • Lucas Research, Inc
        • Hovedetterforsker:
          • Kathryn Lucas
        • Ta kontakt med:
          • Telefonnummer: 252-222-5700 ext. 195
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45229
        • Cincinnati Children's Hospital Medical Center
        • Hovedetterforsker:
          • ROBERT SIEGEL
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic
        • Hovedetterforsker:
          • Roy Kim
        • Ta kontakt med:
          • Telefonnummer: (216) 636-2828
      • Columbus, Ohio, Forente stater, 43205
        • Nationwide Children's Hospital
        • Hovedetterforsker:
          • Joan Han
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104-5008
        • Oklahoma Childrens Memorial Hospital
        • Hovedetterforsker:
          • Jeanie Tryggestad
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29414
        • Coastal Pediatric Associates
        • Hovedetterforsker:
          • Stephen Stripling
        • Ta kontakt med:
          • Telefonnummer: 843-518-5646
      • Charleston, South Carolina, Forente stater, 29425
        • Medical University of South Carolina Children Hospital - PIN
        • Hovedetterforsker:
          • Christine San Giovanni
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37204-3609
        • Vanderbilt Health One Hundred Oaks
        • Hovedetterforsker:
          • Gitanjali Srivastava
    • Texas
      • Austin, Texas, Forente stater, 78723-3079
        • Dell Children's Medical Center - PIN
        • Hovedetterforsker:
          • Gunjan Dokania
      • Corpus Christi, Texas, Forente stater, 78411
        • Driscoll Children's Hospital
        • Hovedetterforsker:
          • Ana Paez
      • Houston, Texas, Forente stater, 77030
        • Texas Childrens Hospital
        • Hovedetterforsker:
          • Stephanie Sisley
      • Houston, Texas, Forente stater, 77030-1521
        • McGovern Medical School
        • Ta kontakt med:
          • Telefonnummer: 713-500-7257
        • Hovedetterforsker:
          • Mona Eissa
    • Virginia
      • Richmond, Virginia, Forente stater, 23229-3156
        • VCU Health - Center for Endocrinology Diabetes and Metabolism
        • Hovedetterforsker:
          • Edmond Wickham
        • Ta kontakt med:
          • Telefonnummer: 804-628-6674
    • Washington
      • Seattle, Washington, Forente stater, 98101
        • Seattle Children's Research Institute - Hughes Building - PIN
        • Hovedetterforsker:
          • Kalie Tommerdale
        • Ta kontakt med:
          • Telefonnummer: (425) 786-3784
      • Tacoma, Washington, Forente stater, 98405
        • MultiCare Health System - Mary Bridge Children's Health Center
        • Hovedetterforsker:
          • Bhuvana Sunil
  • Israel
      • Beer Jacob, Israel, 73100
        • Shamir Medical Center
        • Hovedetterforsker:
          • Marianna Rachmiel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center
        • Hovedetterforsker:
          • Alon Haim
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
        • Hovedetterforsker:
          • Ram Weiss
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
        • Hovedetterforsker:
          • Floris Levy-Khademi
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center
        • Hovedetterforsker:
          • David Zangen
        • Ta kontakt med:
          • Telefonnummer: +972526444664
      • Petah Tikva, Israel, 4920235
        • Schneider Children's Medical Center
        • Hovedetterforsker:
          • Moshe Phillip
  • Italia
      • Florence, Italia, 50139
        • Azienda Ospedaliero Universitaria Meyer
        • Hovedetterforsker:
          • Stefano Stagi
        • Ta kontakt med:
          • Telefonnummer: +390555662305
      • Modena, Italia, 41124
        • Azienda Ospedaliera Universitaria Policlinico de Modena
        • Hovedetterforsker:
          • Barbara Predieri
        • Ta kontakt med:
          • Telefonnummer: +39 059 422 5217
      • Novara, Italia, 28100
        • Azienda Ospedaliero Universitaria Maggiore della Carità
        • Hovedetterforsker:
          • Ivana Rabbone
      • Parma, Italia, 43126
        • Azienda Ospedaliero Universitaria di Parma
        • Hovedetterforsker:
          • Maria Elisabeth Street
        • Ta kontakt med:
          • Telefonnummer: +393206069875
      • Roma, Italia, 165
        • Ospedale Pediatrico Bambino Gesu
        • Hovedetterforsker:
          • Danilo Fintini
        • Ta kontakt med:
          • Telefonnummer: +39 0668593149
  • Mexico
      • Guadalajara, Mexico, 44670
        • PanAmerican Clinical Research - Guadalajara
        • Hovedetterforsker:
          • Ana Lopez Beltran
        • Ta kontakt med:
          • Telefonnummer: +52 3310079299
      • León, Mexico, 37160
        • Centro de Investigacion Farmacologica Del Bajio Sc
        • Ta kontakt med:
          • Telefonnummer: 4773933523
        • Hovedetterforsker:
          • Catalina Peralta Cortázar
      • Monterrey, Mexico, 64060
        • Christus - Latam Hub Center of Excellence and Innovation S.C.
        • Ta kontakt med:
          • Telefonnummer: 8183993400 Ext. 3652
        • Hovedetterforsker:
          • Hector Arriaga Cázares
      • Querétaro, Mexico, 76230
        • Panamerican Clinical Research Mexico
        • Ta kontakt med:
          • Telefonnummer: +52 442 333 2898
        • Hovedetterforsker:
          • Carolina Domínguez Hernández
  • Polen
      • Lodz, Polen, 92-213
        • UMED Clinical Trials
        • Hovedetterforsker:
          • Agnieszka Szadkowska
        • Ta kontakt med:
          • Telefonnummer: +48 42 272 55 55
      • Rzeszów, Polen, 35-301
        • Kliniczny Szpital Wojewódzki Nr 2 im. SW Jadwigi Królowej w Rzeszowie
        • Hovedetterforsker:
          • Artur Mazur
      • Stanisławów Pierwszy, Polen, 05-126
        • ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej
        • Hovedetterforsker:
          • Elzbieta Lipska
        • Ta kontakt med:
          • Telefonnummer: +48 796 30 57 57
      • Warsaw, Polen, 03-291
        • Futuremeds Targowek
        • Hovedetterforsker:
          • Agata Zdanowska
      • Warsaw, Polen, 02 - 696
        • ETG Justmed - PPDS
        • Hovedetterforsker:
          • Marta Szwarc-Bronikowska
      • Warszewo, Polen, 2117
        • Instytut Diabetologii - Warsaw
        • Hovedetterforsker:
          • Ewa Pankowska
      • Wroclaw, Polen, 50-414
        • Premium Clinic Wrocław Centrum Medyczne
        • Hovedetterforsker:
          • Magdalena Bosak Prus
        • Ta kontakt med:
          • Telefonnummer: +48512747682
      • Wroclaw, Polen, 53-673
        • Przychodnia FutureMeds Wrocław
        • Hovedetterforsker:
          • Paulina Ludziak
        • Ta kontakt med:
          • Telefonnummer: 887 803 715
  • Portugal
      • Lisbon, Portugal, 1500-650
        • Hospital da Luz Lisboa
        • Hovedetterforsker:
          • Julia Galhardo
        • Ta kontakt med:
          • Telefonnummer: +351 217 104 520
      • Porto, Portugal, 4100-180
        • Hospital CUF Porto
        • Hovedetterforsker:
          • Carla Rego
        • Ta kontakt med:
          • Telefonnummer: (351) 914-6838 x30
      • Porto, Portugal, 4050-651
        • Centro Materno Infantil do Norte
        • Hovedetterforsker:
          • Helena Mansilha
  • Spania
      • Barcelona, Spania, 08035
        • Hospital Universitario Vall d'Hebron
        • Hovedetterforsker:
          • Eduard Mogas Vinals
        • Ta kontakt med:
          • Telefonnummer: +34 617393140
      • Madrid, Spania, 28009
        • Hospital Infantil Universitario Nino Jesus
        • Hovedetterforsker:
          • Gabriel Martos-Moreno
        • Ta kontakt med:
          • Telefonnummer: +34616531224 ext7351
      • Málaga, Spania, 29011
        • Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
        • Hovedetterforsker:
          • Isabel Leiva Gea
        • Ta kontakt med:
          • Telefonnummer: +34680569397
      • Sabadell, Spania, 8208
        • Corporacio Sanitaria Parc Tauli
        • Hovedetterforsker:
          • Raquel Corripio Collado
        • Ta kontakt med:
          • Telefonnummer: +34937231010 Ex80823
      • Seville, Spania, 41014
        • Instituto Hispalense de Pediatria
        • Hovedetterforsker:
          • Ignacio Salamanca de la Cueva
      • Vitoria-Gasteiz, Spania, 01009
        • Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
        • Hovedetterforsker:
          • Ignacio Diez Lopez
        • Ta kontakt med:
          • Telefonnummer: +34945007030
  • Sør -Korea
      • Seongnam-si, Sør -Korea, 13620
        • Seoul National University Bundang Hospital
        • Hovedetterforsker:
          • Jaehyun Kim
      • Seoul, Sør -Korea, 05505
        • Asan Medical Center
        • Hovedetterforsker:
          • Jin-Ho Choi
      • Seoul, Sør -Korea, 08308
        • Korea University Guro Hospital
        • Hovedetterforsker:
          • Hyo-Kyoung Nam
  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng-Kung Uni. Hosp.
        • Hovedetterforsker:
          • Meng-Che Tsai
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
        • Hovedetterforsker:
          • Yen-Hsuan Ni
      • Taoyuan City, Taiwan, 33305
        • Chang Gung Memorial Hospital - Linkou
        • Hovedetterforsker:
          • Fu-Sung Lo

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

J4M-MC-PW02

  • Are 6 to less than 12 years of age (Tanner stage 1 to 5 inclusive)

  • Have:

    • a body weight of ≥ 40 kilograms (kg) (88 pounds), and
    • been diagnosed with obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart

J4M-MC-PWMP

  • Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening.
  • Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart [CDC-NCHS, 2022])

Exclusion Criteria:

J4M-MC-PW02

  • Have a history of

    • proliferative diabetic retinopathy
    • diabetic macular edema, or
    • nonproliferative diabetic retinopathy that requires acute treatment

J4M-MC-PWMP

  • Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to:

    • gastric bypass
    • sleeve gastrectomy
    • restrictive bariatric surgery, such as Lap-Band® gastric banding, or
    • any other procedure intended to result in weight reduction.
  • Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes.
  • Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state.
  • Have HbA1c >9.0% (75 mmol/mol) as measured by central laboratory at screening.
  • Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Tirzepatid
Deltakerne vil få tirzepatid subkutant (SC)
Legemiddel: Tirzepatid
Administrert SC
Andre navn:
  • LY3298176
Placebo komparator: Placebo
Deltakerne vil motta placebo SC
Legemiddel: Placebo
Administrert SC

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Percent Change from Baseline in Body Mass Index (BMI)
Tidsramme: Baseline, Week 84
Baseline, Week 84

Sekundære resultatmål

Resultatmål
Tidsramme
Change from Baseline in Body Weight
Tidsramme: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Waist Circumference
Tidsramme: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Blood Pressure
Tidsramme: Baseline, Week 84
Baseline, Week 84
Percent Change from Baseline in Total Cholesterol
Tidsramme: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Fasting Glucose
Tidsramme: Baseline, Week 84
Baseline, Week 84
Percent Change from Baseline in Fasting Insulin
Tidsramme: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Score
Tidsramme: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Child Three-Factor Eating Questionnaire (CTFEQr17) Score
Tidsramme: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Height
Tidsramme: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Alanine Aminotransferase (ALT)
Tidsramme: Baseline, Week 84
Baseline, Week 84
Change from Baseline in Aspartate Aminotransferase (AST)
Tidsramme: Baseline, Week 84
Baseline, Week 84
Treatment-Emergent Suicidality from Columbia-Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Baseline, Week 84
Baseline, Week 84
Pharmacokinetics (PK): Average Tirzepatide Concentration at Steady State (Css)
Tidsramme: Baseline through Week 84
Baseline through Week 84

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eli Lilly and Company

Etterforskere

  • Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. desember 2029

Studiet fullført (Antatt)

1. desember 2032

Datoer for studieregistrering

Først innsendt

9. september 2026

Først innsendt som oppfylte QC-kriteriene

9. september 2026

Først lagt ut (Faktiske)

14. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 27090
  • 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • J4M-MC-PWMP Master Protocol (Annen identifikator: Eli Lilly and Company)
  • J4M-MC-PW02 (Annen identifikator: Eli Lilly and Company)
  • 2025-522020-27-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD-delingstidsramme

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Tilgangskriterier for IPD-deling

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere