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NCT06878261RecruitingPhase 3

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
990 (estimated)
First submitted
3 Mar 2025
Start date
25 Mar 2025
Primary completion date
13 Mar 2029
Lead sponsor
AstraZeneca
Diseases
COPD
NCT number
NCT06878261
EU CT number
2024-517457-27-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 990
  • From 25 Mar 2025 to the primary completion date, 13 Mar 2029
  • 250 sites in 22 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Tuberculosis requiring treatment within 12 months prior V2
  • Malignancies current or past
    • Concomitant therapies:
    • Macrolides (less than 6 months)
    • Systemic immuno-suppressive, -modulating medications

Other illness

  • Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
  • Any unstable disorder that can impact participants safety or study outcomes

Other

  • Asthma, incl. pediatric, or ACOS
  • LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT

Who the study is looking for

  • ≥40 to ≤80 years old
  • COPD diagnosis ≥1 year,
  • Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
  • Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1
  • ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy
  • EOS ≥ 150 cells/μL during screening
  • CAT ≥15 at screening
  • Former or current smokers ≥10 pack-years

Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (250)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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AlberdiArgentinaRecruiting
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Buenos AiresArgentinaRecruiting
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Ciudad de Buenos AiresArgentinaRecruiting
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FloridaArgentinaRecruiting
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La PlataArgentinaRecruiting
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Mar del PlataArgentinaRecruiting
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MendozaArgentinaRecruiting
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QuilmesArgentinaRecruiting
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RosarioArgentinaRecruiting
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San FernandoArgentinaRecruiting
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San Juan BautistaArgentinaRecruiting
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Coffs HarbourAustraliaRecruiting
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FrankstonAustraliaRecruiting
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GarranAustraliaWithdrawn
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NedlandsAustraliaRecruiting
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New LambtonAustraliaCompleted
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SpearwoodAustraliaRecruiting
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WollongongAustraliaWithdrawn
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Woodville SouthAustraliaCompleted
Ziekenhuis Oost-Limburg
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GenkBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Brussel
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JetteBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Emmaues
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MechelenBelgiumRecruiting
Meclinas
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MechelenBelgiumRecruiting
Pneumocare
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NamurBelgiumRecruiting
Asclepius Medical Center OOD
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DupnitsaBulgariaRecruiting
Diagnostichno Konsultativen Tsentar 1 Haskovo EOOD
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HaskovoBulgariaRecruiting
Multi-profile Hospital for Active Treatment Heart and Brain EAD
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PlevenBulgariaRecruiting
Medical Center St. Ivan Rilski Chudotvorets 2010 EOOD
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PlovdivBulgariaRecruiting
Medical Center Hermes Ruse Ltd.
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RuseBulgariaRecruiting
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
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SofiaBulgariaRecruiting
Medical Center Pulmovision Ltd.
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SofiaBulgariaRecruiting
Diagnostic-Consultative Center Alexandrovska EOOD
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SofiyaBulgariaRecruiting
Medical Center New Rehabilitation Center EOOD
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Stara ZagoraBulgariaRecruiting
Prevencia 2000 MCDMP
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Stara ZagoraBulgariaRecruiting
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Dr. Treiman EOOD
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Veliko TarnovoBulgariaRecruiting
Medical center Tara Ltd.
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Veliko TirnovoBulgariaRecruiting
Medical Center Sv. Ivan Rilski EOOD
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VidinBulgariaRecruiting
Medical Center Dianamed 2001 EOOD
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YambolBulgariaRecruiting
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ArmeniaColombiaRecruiting
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BarranquillaColombiaRecruiting
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BogotáColombiaRecruiting
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CaliColombiaRecruiting
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IbagueColombiaRecruiting
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ManizalesColombiaRecruiting
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MedellínColombiaRecruiting
Aalborg University Hospital
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AalborgDenmarkRecruiting
Region Hovedstaden
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HvidovreDenmarkRecruiting
Næstved Hospital
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NæstvedDenmarkRecruiting
Odense University Hospital
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Odense CDenmarkRecruiting
Lillebaelt Hospital
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VejleDenmarkRecruiting
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceRecruiting
Hopital De La Croix-Rousse
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Lyon Cedex 04FranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceRecruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceRecruiting
Athens Naval Hospital
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AthensGreeceRecruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceRecruiting
University General Hospital of Heraklion
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HeraklionGreeceRecruiting
University General Hospital of Ioannina
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IoanninaGreeceRecruiting
Athens Medical Center S.A.
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Paleo FaliroGreeceRecruiting
General Hospital Of Patras Agios Andreas
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PatrasGreeceRecruiting
Thermi Clinic S.A.
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ThessalonikiGreeceRecruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceRecruiting
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Hong KongHong Kong SAR ChinaRecruiting
Obudai Egeszseguegyi Centrum Kft.
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Budapest IIIHungaryRecruiting
University of Debrecen
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DebrecenHungaryRecruiting
Edelenyi Koch Robert Korhaz es Rendelointezet
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EdelényHungaryRecruiting
Erzsebet Gondozohaz Kft.
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GödöllőHungaryRecruiting
BKS Research Kft
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HatvanHungaryRecruiting
Omnimodus Elixír Kft.
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MosonmagyaróvárHungaryRecruiting
Simplex Kft.
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NyiregyhazaHungaryRecruiting
Református Pulmonológiai Centrum
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TörökbálintHungaryRecruiting
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AshkelonIsraelRecruiting
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HaifaIsraelRecruiting
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JerusalemIsraelRecruiting
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Kfar SabaIsraelRecruiting
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Ramat GanIsraelRecruiting
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RehovotIsraelRecruiting
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Tel AvivIsraelRecruiting
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Akashi-shiJapanRecruiting
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Chikushino-shiJapanRecruiting
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Chiyoda-kuJapanRecruiting
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Fukui-shiJapanRecruiting
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FukuokaJapanRecruiting
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GifuJapanRecruiting
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Iruma-GunJapanRecruiting
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IshinomakiJapanRecruiting
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Kasuga-shiJapanRecruiting
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Kitakyushu-shiJapanRecruiting
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Kiyose-shiJapanRecruiting
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KobeJapanRecruiting
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Komatsu-shiJapanRecruiting
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Kure-shiJapanRecruiting
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KyotoJapanRecruiting
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Matsusaka-shiJapanRecruiting
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Meguro-kuJapanWithdrawn
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MinatokuJapanRecruiting
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MiyazakiJapanRecruiting
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Mizunami-shiJapanRecruiting
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Nagaoka-shiJapanRecruiting
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NagasakiJapanRecruiting
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NagoyaJapanRecruiting
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Nerima-kuJapanRecruiting
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Ohta-kuJapanWithdrawn
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OkayamaJapanRecruiting
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OsakaJapanRecruiting
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SapporoJapanRecruiting
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SendaiJapanRecruiting
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Shinjuku-kuJapanRecruiting
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ShiogamaJapanRecruiting
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TakamatsuJapanRecruiting
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Takatsuiki-shiJapanWithdrawn
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Tanabe-shiJapanRecruiting
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Toshima-kuJapanWithdrawn
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UbeJapanRecruiting
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YokohamaJapanRecruiting
Catharina Ziekenhuis Stichting
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EindhovenNetherlandsRecruiting
Academisch Ziekenhuis Maastricht
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MaastrichtNetherlandsRecruiting
Ikazia Ziekenhuis
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RotterdamNetherlandsRecruiting
Sint Franciscus Vlietland Groep Stichting
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RotterdamNetherlandsRecruiting
Gelre Hospitals
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ZutphenNetherlandsRecruiting
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AucklandNew ZealandCompleted
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Hamilton WestNew ZealandRecruiting
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TaurangaNew ZealandRecruiting
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CallaoPeruNot yet recruiting
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CuscoPeruWithdrawn
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LimaPeruRecruiting
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PiuraPeruRecruiting
Clinica Pajura SRL
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BucharestRomaniaRecruiting
Spitalul de Urgenta al Ministerului Administratiei si Internelor "Prof. Dr. Dimitrie Gerota"
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BucharestRomaniaRecruiting
Spitalul Clinic de Pneumoftiziologie Leon Daniello
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Cluj-NapocaRomaniaRecruiting
Cabinet Medical de Pneumologie Dr Mincu Bogdan
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Cluj-NapocaRomaniaRecruiting
Spitalul Clinic Judetean De Urgenta Bihor
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OradeaRomaniaRecruiting
Neoclinic Concept S.R.L.
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TimisoaraRomaniaRecruiting
Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara
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TimișoaraRomaniaRecruiting
Fundatia Cardioprevent
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TimișoaraRomaniaRecruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenRecruiting
Blekinge Tekniska Hoegskola
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KarlskronaSwedenRecruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenRecruiting
Region Oerebro Laen
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OrebroSwedenRecruiting
Karolinska University Hospital
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SolnaSwedenRecruiting
Akardo AB
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StockholmSwedenRecruiting
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BangkokThailandRecruiting
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Hat YaiThailandRecruiting
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MuangThailandRecruiting
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MueangThailandRecruiting
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NonthaburiThailandRecruiting
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RayongThailandRecruiting
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AdairsvilleUnited StatesSuspended
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AndersonUnited StatesRecruiting
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Ann ArborUnited StatesRecruiting
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AtlantaUnited StatesRecruiting
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BaltimoreUnited StatesRecruiting
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Bay PinesUnited StatesRecruiting
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BirminghamUnited StatesNot yet recruiting
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BoerneUnited StatesRecruiting
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Bowling GreenUnited StatesRecruiting
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Boynton BeachUnited StatesRecruiting
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CharlotteUnited StatesRecruiting
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ClearwaterUnited StatesCompleted
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ColchesterUnited StatesRecruiting
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ColumbiaUnited StatesRecruiting
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ConcordUnited StatesNot yet recruiting
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CordeleUnited StatesRecruiting
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CullmanUnited StatesRecruiting
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DecaturUnited StatesRecruiting
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El PasoUnited StatesRecruiting
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EvanstonUnited StatesRecruiting
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EvansvilleUnited StatesRecruiting
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EverettUnited StatesRecruiting
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FayettevilleUnited StatesWithdrawn
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Fleming IslandUnited StatesSuspended
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Fort EisenhowerUnited StatesWithdrawn
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GaffneyUnited StatesRecruiting
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Grants PassUnited StatesWithdrawn
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HannibalUnited StatesRecruiting
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HendersonvilleUnited StatesNot yet recruiting
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HinsdaleUnited StatesNot yet recruiting
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HorshamUnited StatesNot yet recruiting
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HoustonUnited StatesRecruiting
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IndianapolisUnited StatesRecruiting
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InglewoodUnited StatesWithdrawn
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JacksonvilleUnited StatesRecruiting
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Kansas CityUnited StatesRecruiting
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KenoshaUnited StatesNot yet recruiting
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KnoxvilleUnited StatesRecruiting
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LebanonUnited StatesNot yet recruiting
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LeesburgUnited StatesRecruiting
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LewisvilleUnited StatesRecruiting
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Little RiverUnited StatesSuspended
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Los AngelesUnited StatesSuspended
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MargateUnited StatesWithdrawn
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McKinneyUnited StatesRecruiting
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MesquiteUnited StatesRecruiting
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MiamiUnited StatesRecruiting
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Miami LakesUnited StatesSuspended
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MinneapolisUnited StatesRecruiting
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New BritainUnited StatesRecruiting
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OcalaUnited StatesRecruiting
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Oklahoma CityUnited StatesRecruiting
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OwensboroUnited StatesRecruiting
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Palmetto BayUnited StatesSuspended
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Palo AltoUnited StatesRecruiting
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PhoenixUnited StatesRecruiting
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PittsburghUnited StatesNot yet recruiting
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PotomacUnited StatesRecruiting
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Rapid CityUnited StatesRecruiting
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ReddingUnited StatesRecruiting
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RosedaleUnited StatesRecruiting
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San AntonioUnited StatesRecruiting
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San DiegoUnited StatesSuspended
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SavannahUnited StatesRecruiting
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SayreUnited StatesRecruiting
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ScottsdaleUnited StatesRecruiting
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SpartanburgUnited StatesRecruiting
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SpringfieldUnited StatesNot yet recruiting
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Staten IslandUnited StatesRecruiting
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SyracuseUnited StatesRecruiting
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The BronxUnited StatesRecruiting
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TulsaUnited StatesRecruiting
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UnionUnited StatesRecruiting
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WilliamsburgUnited StatesRecruiting
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WilmingtonUnited StatesRecruiting
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Winter ParkUnited StatesRecruiting
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Can ThoVietnamNot yet recruiting
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Da NangVietnamRecruiting
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HaiphongVietnamRecruiting
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HanoiVietnamRecruiting
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Hồ Chí MinhVietnamRecruiting
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Ho Chi Minh CityVietnamRecruiting
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HuếVietnamRecruiting
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BellvilleSouth AfricaRecruiting
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BenoniSouth AfricaRecruiting
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Cape TownSouth AfricaRecruiting
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DurbanSouth AfricaRecruiting
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eMkhomaziSouth AfricaRecruiting
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KimberleySouth AfricaWithdrawn
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Somerset WestSouth AfricaRecruiting
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AdanaTurkey (Türkiye)Recruiting
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AnkaraTurkey (Türkiye)Recruiting
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IstanbulTurkey (Türkiye)Recruiting
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KayseriTurkey (Türkiye)Recruiting
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KocaeliTurkey (Türkiye)Recruiting
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MersinTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.