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Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma

maanantai 5. marraskuuta 2018 päivittänyt: MedImmune LLC

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects With Inadequately Controlled, Severe Asthma

The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929 (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

584

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Research Site
      • Sofia, Bulgaria, 1431
        • Research Site
      • Sofia, Bulgaria, 1202
        • Research Site
      • Sofia, Bulgaria, 1233
        • Research Site
      • Sofia, Bulgaria, 1750
        • Research Site
      • Sofia, Bulgaria, 1606
        • Research Site
      • Velingrad, Bulgaria, 4600
        • Research Site
  • Etelä-Afrikka
      • Durban, Etelä-Afrikka, 4068
        • Research Site
      • Middelburg, Etelä-Afrikka, 1055
        • Research Site
      • Pretoria, Etelä-Afrikka, 0181
        • Research Site
      • Pretoria, Etelä-Afrikka, 0183
        • Research Site
  • Israel
      • Ashkelon, Israel, 78278
        • Research Site
      • Haifa, Israel, 34362
        • Research Site
      • Jerusalem, Israel, 91120
        • Research Site
      • Kfar-Saba, Israel, 44281
        • Research Site
      • Petach Tikva, Israel
        • Research Site
      • Rehovot, Israel, 7661041
        • Research Site
      • Tel Hashomer, Israel, 52621
        • Research Site
  • Japani
      • Chuo-ku, Japani, 103-0028
        • Research Site
      • Chuo-ku, Japani, 103-0027
        • Research Site
      • Chuo-ku, Japani, 104-8560
        • Research Site
      • Fujisawa-shi, Japani, 251-8550
        • Research Site
      • Kiyose-shi, Japani, 204-8585
        • Research Site
      • Kurume-shi, Japani, 830-0011
        • Research Site
      • Maebashi-shi, Japani, 371-0054
        • Research Site
      • Ora-gun, Japani, 370-0615
        • Research Site
      • Sagamihara-shi, Japani, 228-0815
        • Research Site
      • Saitama-Ken, Japani, 338-8553
        • Research Site
      • Sapporo-shi, Japani, 060-0033
        • Research Site
      • Taito-ku, Japani, 111-0051
        • Research Site
      • Toshima-ku, Japani, 171-0014
        • Research Site
      • Yokkaichi-shi, Japani, 510-8567
        • Research Site
  • Latvia
      • Daugavpils, Latvia, LV-5401
        • Research Site
      • Rezekne, Latvia, LV-4600
        • Research Site
      • Riga, Latvia, 1001
        • Research Site
      • Riga, Latvia, LV1002
        • Research Site
      • Riga, Latvia, LV-1038
        • Research Site
      • Riga, Latvia, LV1010
        • Research Site
  • Liettua
      • Kaunas, Liettua, LT50009
        • Research Site
      • Klaipeda, Liettua, 92288
        • Research Site
      • Klaipeda, Liettua, 92231
        • Research Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Research Site
      • Kragujevac, Serbia, 34000
        • Research Site
      • Sremska Kamenica, Serbia, 21204
        • Research Site
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • Research Site
      • Bratislava, Slovakia, 84108
        • Research Site
      • Ilava, Slovakia, 01901
        • Research Site
      • Kosice, Slovakia, 040 01
        • Research Site
      • Levice, Slovakia, 934 01
        • Research Site
      • Nove Zamky, Slovakia, 940 01
        • Research Site
      • Poprad, Slovakia, 058 01
        • Research Site
      • Spisska Nova Ves, Slovakia, 052 01
        • Research Site
      • Sturovo, Slovakia, 94301
        • Research Site
      • Surany, Slovakia, 94201
        • Research Site
      • Topolcany, Slovakia, 95501
        • Research Site
      • Zvolen, Slovakia, 96001
        • Research Site
  • Tšekki
      • Brandys nad Labem, Tšekki, 250 01
        • Research Site
      • Hradec Kralove, Tšekki, 500 05
        • Research Site
      • Mlada Boleslav, Tšekki, 293 01
        • Research Site
      • Praha 4, Tšekki, 14059
        • Research Site
      • Praha 8, Tšekki, 180 81
        • Research Site
      • Praha 8, Tšekki, 180 00
        • Research Site
      • Strakonice, Tšekki, 38601
        • Research Site
  • Ukraina
      • Dnipropetrovsk, Ukraina, 49051
        • Research Site
      • Ivano-Frankivsk, Ukraina, 76012
        • Research Site
      • Kyiv, Ukraina, 04050
        • Research Site
      • Kyiv, Ukraina, 02091
        • Research Site
      • Kyiv, Ukraina, 03680
        • Research Site
      • Mykolayiv, Ukraina, 54003
        • Research Site
      • Odessa, Ukraina, 65039
        • Research Site
      • Poltava, Ukraina, 36038
        • Research Site
      • Suprunivka Vil., Poltava Regio, Ukraina, 36028
        • Research Site
      • Vinnytsia, Ukraina, 21029
        • Research Site
      • Zaporizhzhya, Ukraina, 69600
        • Research Site
      • Zaporizhzhya, Ukraina, 69035
        • Research Site
  • Unkari
      • Balassagyarmat, Unkari, 2660
        • Research Site
      • Budapest, Unkari, 1125
        • Research Site
      • Budapest, Unkari, 1529
        • Research Site
      • Budapest, Unkari, 1033
        • Research Site
      • Csorna, Unkari, 9300
        • Research Site
      • Debrecen, Unkari, 4032
        • Research Site
      • Farkasgyepü, Unkari, 8582
        • Research Site
      • Gödöllő, Unkari, 2100
        • Research Site
      • Komarom, Unkari, 2900
        • Research Site
      • Mateszalka, Unkari, 4700
        • Research Site
      • Nagykanizsa, Unkari, 8800
        • Research Site
      • Szeged, Unkari, H-6722
        • Research Site
      • Százhalombatta, Unkari, 2440
        • Research Site
      • Torokbalint, Unkari, 2045
        • Research Site
  • Yhdysvallat
    • California
      • Los Angeles, California, Yhdysvallat, 90025
        • Research Site
      • Los Angeles, California, Yhdysvallat, 90048
        • Research Site
    • Florida
      • Miami, Florida, Yhdysvallat, 33133
        • Research Site
      • Oviedo, Florida, Yhdysvallat, 32765
        • Research Site
    • Georgia
      • Savannah, Georgia, Yhdysvallat, 31406
        • Research Site
    • Illinois
      • Peoria, Illinois, Yhdysvallat, 61602
        • Research Site
    • Maryland
      • Baltimore, Maryland, Yhdysvallat, 21224
        • Research Site
    • Minnesota
      • Rochester, Minnesota, Yhdysvallat, 55905
        • Research Site
    • New York
      • New York, New York, Yhdysvallat, 10016
        • Research Site
      • New York, New York, Yhdysvallat, 10029
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, Yhdysvallat, 28277
        • Research Site
      • Charlotte, North Carolina, Yhdysvallat, 28207
        • Research Site
    • Ohio
      • Dublin, Ohio, Yhdysvallat, 43016
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Yhdysvallat, 73120
        • Research Site
    • South Carolina
      • Rock Hill, South Carolina, Yhdysvallat, 29732
        • Research Site
      • Spartanburg, South Carolina, Yhdysvallat, 29303
        • Research Site
    • Texas
      • Houston, Texas, Yhdysvallat, 77070
        • Research Site
    • Virginia
      • Richmond, Virginia, Yhdysvallat, 23220
        • Research Site

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 75 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  • Age 18 through 75
  • Body mass index (BMI) between 18-40 kg/m2 and weight greater than or equal 40 kg
  • Documented physician-diagnosed asthma - Subjects must have received a physician-prescribed asthma controller regimen with medium- or high-dose inhaled corticosteroids (ICS) plus long acting β2 agonist (LABA) -If on asthma controller medications in addition to ICS plus LABA, the dose of the other asthma controller medications (leukotriene receptor inhibitors, theophylline, secondary ICS, long-acting anti-muscarinics (LAMA), cromones, or maintenance oral prednisone or equivalent up to a maximum of 10 mg daily or 20 mg every other day for the maintenance treatment of asthma) must be stable. -Subjects must have a documented history of at least 2 asthma exacerbation events OR at least 1 severe asthma exacerbation resulting in hospitalization within the 12 months prior to first study visit.

Exclusion Criteria:

  • Diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation and panic attacks, or other mimics of asthma.
  • Current smokers or subjects with a smoking history of ≥ 10 pack years
  • Former smokers with < 10 pack years must have stopped for at least 1 year to be eligible.
  • Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (eg, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome).
  • Evidence of active liver disease.
  • History of Cancer, except for basal cell carcinoma or insitu carcinoma of the cervix treated with apparent success with curative therapy or other malignancies are eligible provided that curative therapy was completed -Known history of active tuberculosis (TB)
  • History of anaphylaxis to any biologic therapy
  • Positive medical history for hepatitis B or C
  • Subject with human immunodeficiency virus (HIV) or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Placebo Comparator: Placebo
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Lääke: Placebo
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Kokeellinen: MEDI9929 70 mg
Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
Lääke: MEDI9929 70 mg
Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
Kokeellinen: MEDI9929 210 mg
Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
Lääke: MEDI9929 210 mg
Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
Kokeellinen: MEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Lääke: MEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Annualized Asthma Exacerbation Rate (AER) Through Week 52
Aikaikkuna: Week 0 (Day 1) up to Week 52
Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
Week 0 (Day 1) up to Week 52

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Reduction in AER on Subpopulations at Week 52
Aikaikkuna: Week 52
Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Reduction in AER was evaluated in pre-specified subpopulations (blood eosinophil count [eosinophilic and non-eosinophilic], T helper cell 2 [Th2] status [high and low], Fraction of exhaled nitric oxide [FENO] [high and low], serum periostin [high and low], current post bronchodilator forced expiratory volume in 1 second [Post-BD FEV1] reversibility- yes, allergic and non-allergic) of asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up. Also, the high or low was determined using median value.
Week 52
Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52
Aikaikkuna: Baseline (Week 0 [Day 1]) to Week 52
Forced expiratory volume in 1 second and forced vital capacity measures taken before bronchodilator use were reported.
Baseline (Week 0 [Day 1]) to Week 52
Change From Baseline in FEV1 on Subpopulations at Week 52
Aikaikkuna: Baseline and up to Week 52
Forced expiratory volume in one second (FEV1) was evaluated in pre-specified subpopulations of asthma. The data presented in the below table for this outcome measure is for pre-bronchodilator FEV1.
Baseline and up to Week 52
Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52
Aikaikkuna: Baseline (Week 0 [Day 1]) to Week 52
Forced expiratory volume in 1 second and forced vital capacity measures taken after bronchodilator use were reported.
Baseline (Week 0 [Day 1]) to Week 52
Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52
Aikaikkuna: Baseline and up to Week 52
Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary. Overall symptom score is the average of scores of daytime severity, daytime frequency, and nighttime severity symptoms. The daytime frequency and severity items are scored from 0 to 4, where a higher score indicates greater frequency/severity and nighttime severity item is scored from 0 to 4 , where a higher score indicates greater severity. Overall symptom score ranges from 0 to 4, where lower score indicates better asthma symptom while, higher score indicates worse asthma symptom.
Baseline and up to Week 52
Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52
Aikaikkuna: Baseline (Week 0 [Day 1]) and Week 52
Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary. Symptom score values for night time assessment is 0 (no asthma symptom) to 3 (unable to sleep because of asthma) and symptom score values for day time assessment is 0 (no asthma symptom) to 3 (unable to do normal activities due to asthma). Total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom.
Baseline (Week 0 [Day 1]) and Week 52
Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52
Aikaikkuna: Baseline (Week 0 [Day 1]) and Week 52
The ACQ is a patient-reported questionnaire assessing asthma symptoms (ie, night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use and FEV1. The ACQ-6 is a shortened version of the ACQ that omits the FEV1 measurement from the original ACQ score. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled).
Baseline (Week 0 [Day 1]) and Week 52
Rate of Severe Asthma Exacerbation Through Week 52
Aikaikkuna: Week 0 (Day 1) up to Week 52
A severe asthma exacerbation is defined as an event that resulted in hospitalization. The severe AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
Week 0 (Day 1) up to Week 52
Time to First Asthma Exacerbation Through Week 52
Aikaikkuna: Week 0 (Day 1) through Week 52
Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first asthma exacerbation was reported.
Week 0 (Day 1) through Week 52
Time to First Severe Asthma Exacerbation Through Week 52
Aikaikkuna: Week 0 (Day 1) through Week 52
Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first severe asthma exacerbations (hospitalization) were reported.
Week 0 (Day 1) through Week 52
Number of Participants With at Least One Asthma Exacerbations Through Week 52
Aikaikkuna: Week 0 (Day 1) through Week 52
Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma.
Week 0 (Day 1) through Week 52
Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52
Aikaikkuna: Week 0 (Day 1) through Week 52
Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Participants with severe asthma exacerbations (hospitalization) were reported.
Week 0 (Day 1) through Week 52
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52
Aikaikkuna: Baseline (Week 0 [Day 1]) and Week 52
The AQLQ(S) +12 is a 32-item questionnaire that measures the health-related quality of life experienced by asthma participants. The questionnaire comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli) scaled on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment).
Baseline (Week 0 [Day 1]) and Week 52
Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52
Aikaikkuna: Baseline (Week 0 [Day 1]) and Week 52
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a visual analogue scale (VAS) that ranged from 0 to 100, where 0 indicated the worst health you can imagine and 100 indicated the best health you can imagine.
Baseline (Week 0 [Day 1]) and Week 52
Total Amount of Study Drug Exposure
Aikaikkuna: Week 0 (Day 1) through Week 52
The total amount of study drug exposure (in milligram) for the entire study period was summarized.
Week 0 (Day 1) through Week 52
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Aikaikkuna: Day 1 upto Week 64
An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any adverse event that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period until and including the follow-up period (Week 64).
Day 1 upto Week 64
Number of Participants With TEAEs Related to Vital Sign Parameters
Aikaikkuna: Day 1 upto Week 64
Adverse events observed in participants with clinically significant vital signs abnormalities were assessed.
Day 1 upto Week 64
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Aikaikkuna: Day 1 upto Week 64
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations of blood and urine samples were performed.
Day 1 upto Week 64
Number of Participants With TEAEs Related to Electrocardiogram Evaluations
Aikaikkuna: From the start of study drug administration upto Week 64
Adverse events observed in participants with clinically significant electrocardiogram abnormalities were assessed.
From the start of study drug administration upto Week 64
Mean Serum Concentrations of MEDI9929
Aikaikkuna: Week 0 (Day 1) to Week 64
The mean serum concentrations of MEDI9929 was observed at specified timepoints.
Week 0 (Day 1) to Week 64
Number of Participants With Positive Antibodies to MEDI9929
Aikaikkuna: Week 0 (Day 1) to Week 64
Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9929. The number of participants with positive serum antibodies to MEDI9929 were presented.
Week 0 (Day 1) to Week 64

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

MedImmune LLC

Yhteistyökumppanit

Amgen

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Perjantai 13. joulukuuta 2013

Ensisijainen valmistuminen (Todellinen)

Maanantai 12. joulukuuta 2016

Opintojen valmistuminen (Todellinen)

Keskiviikko 1. maaliskuuta 2017

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 4. joulukuuta 2013

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 3. helmikuuta 2014

Ensimmäinen Lähetetty (Arvio)

Tiistai 4. helmikuuta 2014

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Tiistai 4. joulukuuta 2018

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 5. marraskuuta 2018

Viimeksi vahvistettu

Torstai 1. marraskuuta 2018

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • CD-RI-MEDI9929-1146
  • 2013-003269-33 (EudraCT-numero)

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Netherlands

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

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Sijainnit

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