AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea (AMAZE 3)
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure (AMAZE 3)
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Studiesteder
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New South Wales
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Macquarie Park, New South Wales, Australien, 2113
- Rekruttering
- Woolcock Institute
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Queensland
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Birtinya, Queensland, Australien, 4575
- Rekruttering
- University of Sunshine Coast - Vitality Village
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South Brisbane, Queensland, Australien, 4101
- Ikke rekrutterer endnu
- Mater Research - RIO Clinical Trials Unit
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South Australia
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Adelaide, South Australia, Australien, 5000
- Rekruttering
- Nightingale Research Adelaide
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Western Australia
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Crawley, Western Australia, Australien, 6009
- Rekruttering
- University of Western Australia - Centre for Sleep Science
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Herning, Danmark, 7400
- Rekruttering
- Regionshospitalet Gødstrup, Øre-næse-hals-kirurgisk
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Køge, Danmark, 4600
- Rekruttering
- Sjællands Universitetshospital, Køge - Øre-Næse-Hals afdeling
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California
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San Diego, California, Forenede Stater, 92123
- Rekruttering
- Artemis Insitute for Clin Res
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Florida
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Miami, Florida, Forenede Stater, 33176
- Rekruttering
- PharmaDev Clinical Research Institute LLC
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Naples, Florida, Forenede Stater, 34102
- Ikke rekrutterer endnu
- Essence MD Research
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Ocala, Florida, Forenede Stater, 34470
- Rekruttering
- Renstar Medical Research
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Georgia
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Atlanta, Georgia, Forenede Stater, 30328
- Rekruttering
- Conquest Research
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Lawrenceville, Georgia, Forenede Stater, 30046
- Rekruttering
- Physicians Research Associates
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- Rekruttering
- University of Chicago
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New York
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New York, New York, Forenede Stater, 10021
- Rekruttering
- Weil Cornell Medicine
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45212
- Rekruttering
- CTI Clinical Research Center
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Pennsylvania
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DuBois, Pennsylvania, Forenede Stater, 15801
- Ikke rekrutterer endnu
- Clinical Research Associates of Central PA, LLC
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Texas
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DeSoto, Texas, Forenede Stater, 75115
- Rekruttering
- Epic Medical Research
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El Paso, Texas, Forenede Stater, 79912
- Rekruttering
- Advanced Neurology Epilepsy and Sleep Center ANESC
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El Paso, Texas, Forenede Stater, 79912
- Rekruttering
- Biorhythms Center for Integrative Sleep Medicine
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Houston, Texas, Forenede Stater, 77089
- Rekruttering
- Houston Pulm Med Res Network
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San Antonio, Texas, Forenede Stater, 78229
- Rekruttering
- Sleep Therapy Research Center
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Sugar Land, Texas, Forenede Stater, 77478
- Rekruttering
- Tricoastal Sleep Center
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Washington
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Renton, Washington, Forenede Stater, 98057
- Rekruttering
- Rainier Clin Res Ctr Inc
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Jaipur, Indien, 302039
- Rekruttering
- Asthma Bhawan
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New Delhi, Indien, 110029
- Rekruttering
- Vardhaman Mahavir Medical College & Safdarjung Hospital
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Andhra Pradesh
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Guntur, Andhra Pradesh, Indien, 522004,
- Afsluttet
- Guntur Government medical College
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Vijayawada, Andhra Pradesh, Indien, 520008
- Rekruttering
- Government Siddhartha Medical College & Government General Hospital, Vijayawada
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Karnataka
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Bengaluru, Karnataka, Indien, 560074
- Rekruttering
- Rajarajeswari Medical College and Hospital
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Kerala
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Kochi, Kerala, Indien, 682041
- Rekruttering
- Amrita Institute of Medical Sciences & Research Centre
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Maharashtra
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Mumbai, Maharashtra, Indien, 401107
- Rekruttering
- Bhaktivedanta Hospital & Research Institute
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Nagpur, Maharashtra, Indien, 440010
- Rekruttering
- Asian Kidney Hospital And Medical Centre
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New Delhi
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Delhi, New Delhi, Indien, 110029
- Ikke rekrutterer endnu
- All India Institute of Medical Sciences_Delhi
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Odisha
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Bhubaneswar, Odisha, Indien, 751019
- Ikke rekrutterer endnu
- All India Institute of Medical Sciences (AIIMS), Bhubaneswar
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Telangana
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Hyderabad, Telangana, Indien, 500084
- Afsluttet
- Yashoda Hospital
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Uttar Pradesh
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Lucknow, Uttar Pradesh, Indien, 226006
- Rekruttering
- Midland Healthcare & Research Center
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West Bengal
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Kolkata, West Bengal, Indien, 700054
- Rekruttering
- Apollo Multispeciality Hospital, Kolkata
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100044
- Rekruttering
- Peking University People's Hospital-Endocrinology
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Jiangsu
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Nanjing, Jiangsu, Kina, 210011
- Rekruttering
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
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Suzhou, Jiangsu, Kina, 215006
- Rekruttering
- The First Affiliated Hospital of Soochow University-Endocrinology
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Zhenjiang, Jiangsu, Kina, 212001
- Rekruttering
- The Affiliated Hospital of Jiangsu University-Endocrinology
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Zhejiang
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Huzhou, Zhejiang, Kina, 313000
- Rekruttering
- Huzhou Central Hospital-Endocrinology
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Gdansk, Polen, 80-214
- Rekruttering
- Uniwersyteckie Centrum Kliniczne
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Gdansk, Polen, 80-546
- Rekruttering
- Penta Hospitals Badania Kliniczne Sp. z o.o.
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Krakow, Polen, 31-202
- Afsluttet
- Krakowski Szpital Specjalistyczny im. Jana Pawla II
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Krakow, Polen, 30-901
- Rekruttering
- 5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
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Poznan, Polen, 60-569
- Rekruttering
- Uniwersytecki Szpital Kliniczny W Poznaniu
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Warsaw, Polen, 02-507
- Rekruttering
- Państwowy Instytut Medyczny MSWiA
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Warsaw, Polen, 02-677
- Rekruttering
- ETG Warszawa Sp. z o.o.
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Warsaw, Polen, 01-138
- Rekruttering
- National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc
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Warsaw, Polen, 00-124
- Rekruttering
- Gyncentrum Sp. z o. o.
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Dolnoslaskie Voivodeship
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Wroclaw, Dolnoslaskie Voivodeship, Polen, 50-981
- Rekruttering
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
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Barcelona, Spanien, 08035
- Rekruttering
- Hospital Vall d'hebrón
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Castilleja de la Cuesta, Spanien, 41950
- Rekruttering
- Hospital Vithas Sevilla
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Lleida, Spanien, 25198
- Rekruttering
- Hospital Univ. de Santa María de Lleida
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Logroño, Spanien, 26006
- Rekruttering
- Hospital Universitario San Pedro
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Madrid, Spanien, 28034
- Rekruttering
- Hospital Ramon y Cajal
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Madrid, Spanien, 28036
- Rekruttering
- Instituto de Investigaciones del Sueño
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Vitoria-Gasteiz, Spanien, 01004
- Rekruttering
- Hospital Universitario de Araba
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Castille-La Mancha
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Guadalajara, Castille-La Mancha, Spanien, 19002
- Rekruttering
- Hospital Universitario de Guadalajara
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Madrid
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Pozuelo de Alarcón, Madrid, Spanien, 28223
- Rekruttering
- H.U. Quirónsalud Madrid
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Chiayi City, Taiwan, 600
- Ikke rekrutterer endnu
- Ditmanson Medical Foundation Chia-Yi Christian Hospital
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Taipei, Taiwan, 110
- Rekruttering
- Taipei Medical University Hospital
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Taipei, Taiwan, 106
- Rekruttering
- Cathay General Hospital
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Taipei, Taiwan, 116
- Rekruttering
- Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology
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Taoyuan, Taiwan, 333
- Rekruttering
- Chang Gung Memorial Hospital, Linkou
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Alanya/ Antalya, Tyrkiet (Türkiye), 07400
- Rekruttering
- T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
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Maltepe/İstanbull, Tyrkiet (Türkiye), 34843
- Rekruttering
- İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi
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Merkez/Battalgazi/Malatya, Tyrkiet (Türkiye), 44280
- Rekruttering
- İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları
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Merkez/Çorum, Tyrkiet (Türkiye), 19040
- Rekruttering
- Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
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Yenimahalle / Ankara, Tyrkiet (Türkiye), 06170
- Rekruttering
- Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları
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Yuregir/Adana, Tyrkiet (Türkiye), 01060
- Rekruttering
- Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye
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Yıldırım/Bursa, Tyrkiet (Türkiye), 16310
- Rekruttering
- Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları
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Zeytinburnu/İstanbul, Tyrkiet (Türkiye), 34020
- Rekruttering
- Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
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Bochum, Tyskland, 44787
- Rekruttering
- Siteworks GmbH Bochum
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Hamburg, Tyskland, 22607
- Rekruttering
- Wendisch - Dahl Hamburg - DZHW
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Hanover, Tyskland, 30449
- Rekruttering
- Siteworks GmbH Hannover
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Karlsruhe, Tyskland, 76137
- Rekruttering
- Siteworks GmbH Karlsruhe
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Münster, Tyskland, 48145
- Rekruttering
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
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Schleswig, Tyskland, 24837
- Rekruttering
- Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Key Inclusion Criteria:
- Male or female (sex at birth)
- Age 18 years or above at the time of signing informed consent
- Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening
Key Exclusion Criteria:
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening
- History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records
- Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy
- Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence
- Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Deltagerne vil modtage placebo svarende til NNC0487-0111 subkutant en gang om ugen som supplement til en kaloriereduceret kost og øget fysisk aktivitet.
|
Placebo svarende til NNC0487-0111 vil blive administreret subkutant ved hjælp af PDS290 fyldte pen-injektorer til en af kropsdelene: lår, mave eller overarm.
|
|
Eksperimentel: NNC0487-0111
Deltagerne vil blive randomiseret til at modtage 1 af de 2 doseniveauer af NNC0487-0111 subkutant en gang om ugen som et supplement til en kaloriereduceret diæt og øget fysisk aktivitet.
|
NNC0487-0111 vil blive administreret subkutant ved hjælp af PDS290 præfyldte pen-injektorer til en af følgende kropsdele: lår, mave eller overarm.
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Relative change in body weight
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as percentage (%) change in body weight.
|
From baseline (week 0) to (week 80)
|
|
Change in apnoea-hypopnoea index (AHI)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as events/hour.
|
From baseline (week 0) to (week 80)
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ændring i taljemål
Tidsramme: Fra baseline (uge 0) til (uge 80)
|
Målt i centimeter (cm).
|
Fra baseline (uge 0) til (uge 80)
|
|
Ændring i systolisk blodtryk (SBP)
Tidsramme: Fra baseline (uge 0) til (uge 80)
|
Målt i millimeter kviksølv (mmHg).
|
Fra baseline (uge 0) til (uge 80)
|
|
Ændring i diastolisk blodtryk (DBP)
Tidsramme: Fra baseline (uge 0) til (uge 80)
|
Målt i mmHg.
|
Fra baseline (uge 0) til (uge 80)
|
|
Antal TEAE'er, der førte til permanent behandlingsafbrydelse
Tidsramme: Fra baseline (uge 0) til uge 84
|
Målt som hændelser.
|
Fra baseline (uge 0) til uge 84
|
|
Relative change in AHI
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as percentage change in AHI.
|
From baseline (week 0) to (week 80)
|
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Achievement of 50% reduction in AHI (Yes/No)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as number of participant.
|
From baseline (week 0) to (week 80)
|
|
Achievement of: AHI less than (<) 5
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Change in ESS score
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as score on a scale.
ESS measures the level of daytime sleepiness or average sleep propensity.
The measure consists of 8 items yielding one total score.
Total score ranges from 0-24.
Higher scores indicate higher sleepiness or average sleep propensity in daily life.
|
From baseline (week 0) to (week 80)
|
|
Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as score on a scale. PROMIS-SD measures perceptions of sleep quality, sleep depth, and restoration associated with sleep. The measure consists of 8 items each rated on a 5-point scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good". Individual item scores will be combined and converted to a T-score using a response pattern scoring approach. The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10. Total score (T-score range): Sleep disturbance (ranging approximately from 30-80.1). Higher scores indicate more sleep disturbance. |
From baseline (week 0) to (week 80)
|
|
Change in body weight
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as kilogram (Kg).
|
From baseline (week 0) to (week 80)
|
|
Change in body mass index (BMI)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as kilograms per meter square (kg/m^2).
|
From baseline (week 0) to (week 80)
|
|
Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Change in neck circumference
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as cm.
|
From baseline (week 0) to (week 80)
|
|
Change in Total cholesterol
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in High-density lipoprotein (HDL) cholesterol
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in Low-density lipoprotein (LDL) cholesterol
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in Non-HDL cholesterol
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in Triglycerides
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in fasting plasma glucose
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as millimoles per litre (mmol/L).
|
From baseline (week 0) to (week 80)
|
|
Number of Treatment emergent adverse events (TEAEs)
Tidsramme: From baseline (week 0) to week 84
|
Measured as events.
|
From baseline (week 0) to week 84
|
|
Number of Treatment emergent serious adverse events (TESAEs)
Tidsramme: From baseline (week 0) to week 84
|
Measured as Events.
|
From baseline (week 0) to week 84
|
|
Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)
Tidsramme: From baseline (week 0) to (week 80)
|
Measures as number of participants
|
From baseline (week 0) to (week 80)
|
|
Change in sleep apnoea specific hypoxic burden (SASHB)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as percentage minutes per hour (%min/h).
|
From baseline (week 0) to (week 80)
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as score on a scale.
PROMIS-SRI measures perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness.
The measure consists of 8 items each rated on a 5-point scale ranging from "not at all" to "very much".
Individual item scores will be combined and converted to a T-score using a response pattern scoring approach.
The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10.
Total score (T-score range): Sleep-related impairment (ranging approximately from 30-80.1).
Higher scores indicate more sleep-related impairment.
|
From baseline (week 0) to (week 80)
|
|
Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 5 and < 15/hour = mild (Yes/No)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 15 and < 30/hour = moderate (Yes/No)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 30/hour = severe (Yes/No)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as number of participants.
|
From baseline (week 0) to (week 80)
|
|
Change in high-sensitivity C-reactive protein (hsCRP)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline
|
From baseline (week 0) to (week 80)
|
|
Chage in Very low-density lipoprotein (VLDL) cholesterol
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as ratio to baseline.
|
From baseline (week 0) to (week 80)
|
|
Change in glycated haemoglobin (HbA1c)
Tidsramme: From baseline (week 0) to (week 80)
|
Measured as % of HbA1c.
|
From baseline (week 0) to (week 80)
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Clinical Transparency dept. 2834, Novo Nordisk A/S
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i nervesystemet
- Ernæringsforstyrrelser
- Overernæring
- Kropsvægt
- Luftvejssygdomme
- Respirationsforstyrrelser
- Søvnvågningsforstyrrelser
- Apnø
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnapnø syndromer
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Overvægtig
- Fedme
- Søvnapnø, obstruktiv
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- NN9490-8025
- U1111-1313-6359 (Anden identifikator: World Health Organization (WHO))
- 2024-520442-36 (Anden identifikator: European Medical Agency (EMA))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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