A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well
TENACITY
TENACITY - A Phase III, Prospective, Randomized, Open-label, Blinded Endpoint Assessment (PROBE) to Assess Efficacy and Safety of i.v. Tenecteplase vs Standard of Care in Patients With Acute Ischemic Stroke (Including Wake-up Stroke), Last Known Well >4.5 h With Imaging Evidence of Salvageable Ischemic Tissue
4 other identifiers
interventional
1,325
16 countries
254
Brief Summary
This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke). This study is for people who had an acute stroke or woke up with a stroke and were last seen well more than 4.5 hours before joining the study. Participants need to have imaging that shows there is brain tissue that can still be saved. They also should not be planned to receive a procedure to remove the blood clot. The purpose of this study is to find out whether a medicine called tenecteplase helps people recover from an acute stroke. Tenecteplase is already used to treat people within 4.5 hours after they had a stroke. This study tests if tenecteplase also helps if it is given more than 4.5 hours after the stroke. Participants are put into 2 groups randomly, which means by chance. One group gets tenecteplase as a single injection into a vein. The other group receives standard medical practice. Participants have an equal chance of receiving tenecteplase or the standard treatment. Participants are in the study for about 3 months. In the beginning, participants stay in the hospital for about 1 week. During the study, participants have 7 clinical examinations or visits. The last 2 of these visits will likely be done from home, allowing participants to complete certain assessments remotely. Doctors regularly test participants' recovery using a scale that measures the level of disability or dependence in daily activities. The results are compared between the 2 groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2026
254 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2026
CompletedFirst Posted
Study publicly available on registry
January 23, 2026
CompletedStudy Start
First participant enrolled
February 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 2, 2027
September 29, 2026
September 1, 2026
1.6 years
January 14, 2026
September 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
modified Rankin Scale (mRS) score of 0-1 at Day 90
The Modified Rankin Scale, MRS, is a tool used to evaluate disability after a stroke. The score ranges from 0 to 6, with higher values indicating greater severity of the disability.
at day 90
Secondary Outcomes (6)
mRS (ordinal) at Day 90
at day 90
Early neurological improvement (reduction in acute - 24-hour National Institute of Health Stroke Scale (NIHSS) score of ≥8 or value of 0/1)
at baseline/randomisation, 24 hours after randomization
mRS 0-2 at Day 90
at Day 90
Symptomatic intracranial haemorrhage (sICH) as defined by Safety Implementation of Thrombolysis in Stroke: Monitoring Study (SITS-MOST) criteria at 36 h
after 36 hours
sICH as defined by European Cooperative Acute Stroke Study (ECASS) III criteria at 36 h
after 36 hours
- +1 more secondary outcomes
Study Arms (2)
Tenecteplase treatment arm
EXPERIMENTALStandard of care treatment arm
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation (anterior cerebral artery (ACA), middle cerebral artery (MCA), and posterior cerebral arteries (PCA)) last known well \>4.5 h before time of presumed randomisation
- Pre-stroke modified Rankin scale (mRS) ≤1
- Imaging eligibility by magnetic resonance imaging (MRI)computed tomography (CT)
You may not qualify if:
- Intention to proceed to mechanical thrombectomy (MT) at the same site (hospital) of randomisation
- Occlusion of the internal carotid artery (ICA)
- High-risk patients (increased risk of thrombolysis related hemorrhage)
- Any intracranial hemorrhage detected on non-contrast computed tomography (NCCT) or MRI scans
- Contra-indication to contrast brain imaging with CT and MRI
- Severe stroke as assessed clinically (National Institute of Health Stroke Scale (NIHSS) \> 25)
- Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator
- Imaging or clinical findings not indicative of acute ischemic stroke or suggesting stroke older than 72 h
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (254)
Sanatorio Güemes
Buenos Aires, C1180AAX, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, 1199, Argentina
CEMIC
Ciudad Autonoma Buenos Aires, 1431, Argentina
Hospital General de Agudos Dr. J. M. Ramos Mejia
Ciudad Autonoma Buenos Aires, C1221ADC, Argentina
Clinica La Sagrada Familia
Ciudad Autonoma Buenos Aires, C1426EOB, Argentina
Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI
Ciudad Autonoma Buenos Aires, C1428AQK, Argentina
Complejo Medico de la Policia Federal Argentina Churruca Visca
Ciudad Autonoma Buenos Aires, C1437JCP, Argentina
Clinica Privada Velez Sarfield
Córdoba, 5000, Argentina
Nuevo Hospital San Roque
Córdoba, 5000, Argentina
Sanatorio Allende
Córdoba, 5000, Argentina
Sanatorio Privado Duarte Quiros De Clinica Colombo SA
Córdoba, 5000, Argentina
Sanatorio de la Canada
Córdoba, X5000BSQ, Argentina
Hospital Cordoba
Córdoba, X5004CDT, Argentina
Hospital Privado de Comunidad
Mar del Plata, B7602CBM, Argentina
Hospital Universitario Austral
Pilar, B1629ODT, Argentina
Hospital Privado de Rosario
Rosario, S2000GAP, Argentina
Campbelltown Hospital
Campbelltown, New South Wales, 2560, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Eastern Health-Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
MHAT "Puls" AD
Blagoevgrad, 2700, Bulgaria
MHAT Blagoevgrad, EOOD
Blagoevgrad, 2700, Bulgaria
MHAT Heart and brain
Burgas, 8000, Bulgaria
MHAT Sv. Ivan Rilski EOOD
Gorna Oryahovitsa, 5100, Bulgaria
MHAT City Clinic Saint Georgi Ltd
Montana, 3400, Bulgaria
MHAT Heart and brain
Pleven, 5800, Bulgaria
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Pleven, 5803, Bulgaria
UMHAT "Kaspela", EOOD
Plovdiv, 4000, Bulgaria
UMHAT "Sv. Georgi", EAD
Plovdiv, 4002, Bulgaria
UMHAT Kanev AD
Rousse, 7000, Bulgaria
UMHAT "Medika Ruse" OOD
Rousse, 7013, Bulgaria
MHAT "Hadzhi Dimitar" OOD
Silven, 8800, Bulgaria
MHATNP "Sv. Naum" EAD
Sofia, 1113, Bulgaria
University First MHAT-Sofia "St. Joan Krastitel" EAD
Sofia, 1142, Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD
Sofia, 1407, Bulgaria
Medical Military Academy MHAT Sofia
Sofia, 1606, Bulgaria
Multiprofile Hospital MHATEM 'Pirogov', Sofia
Sofia, 1606, Bulgaria
University Hospital St. Anna
Sofia, 1750, Bulgaria
MHAT 'Sv. Anna - Varna' AD
Varna, 9002, Bulgaria
The People's Hospital of Anyang City
Anyang, 455002, China
Baoji Central Hospital
Baoji, 721008, China
Inner Mongolia Baogang Hospital
Baotou, 14010, China
Cap Med University
Beijing, 100069, China
Peking University Third Hospital
Beijing, 100191, China
Hebei Cangzhou Central Hospital
Cangzhou, 61001, China
Jilin Cancer Hospital
Changchun, 130000, China
Hunan Provincial People's Hospital
Changsha, 410005, China
Chengdu Second People's Hospital
Chengdu, 610021, China
Chifeng Traditional Chinese and Mongolian Medicine Hospital
Chifeng, 24005, China
Daqing Longnan Hospital
Daqing, 163000, China
Daqing Oilfield General Hospital
Daqing, 163001, China
The First People's Hospital of Foshan
Foshan, 528000, China
General Hospital of Fushun Mining Bureau
Fushun, 113008, China
Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510150, China
The Second Hospital of Harbin Medical University
Haerbin, 150086, China
The First Affiliated Hospital of University of South China
Hengyang, 421001, China
Huai'an Second People's Hospital
Huai'an, 223002, China
Huizhou Central People's Hospital
Huizhou, 516001, China
Huizhou First Hospital
Huizhou, 516003, China
Meihekou Central Hospital
Jilin City, 135000, China
Jinhua Municipal Central Hospital
Jinhua, 321000, China
Jining No.1 People's Hospital
Jining, 272011, China
Affiliated Hospital of Jiujiang University
Jiujiang, 332000, China
First People's Hospital of Yunnan Province
Kunming, 650032, China
Liaocheng People's Hospital
Liaocheng, 252000, China
Linfen Central Hospital
Linfen, 041000, China
Linyi People's Hospital
Linyi, 276005, China
Lu'an People's Hospital
Lu'an, 237005, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471000, China
Luoyang Central Hospital
Luoyang, 471009, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011, China
Nanyang Central Hospital
Nanyang, 473000, China
Nanyang Nanshi Hospital
Nanyang, 473001, China
Pingxiang People's Hospital
Pingxiang, 337055, China
Qingdao Central Hospital
Qingdao, 266024, China
Qingdao Municipal Hospital
Qingdao, 266071, China
Huashan Hospital, Fudan University
Shanghai, 200040, China
Shanghai Tenth People's Hospital
Shanghai, 200072, China
Shangrao People's Hospital
Shangrao, 334000, China
Yuebei People's Hospital
Shaoguan, 512026, China
Affiliated Central Hospital of Shenyang Medical College
Shenyang, 110000, China
The First People's Hospital of Shenyang
Shenyang, 110000, China
Hebei General Hospital
Shijiazhuang, 500051, China
Sichuan Provincial People's Hospital
Sichuan, 610031, China
Shanxi Cardiovascular Hospital
Taiyuan, 30013, China
The First People's Hospital of Tancheng
Tengzhou, 276199, China
Weifang People's Hospital
Weifang, 261000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
The Central Hospital of Wuhan
Wuhan, 430014, China
Wuhan Puai Hospital
Wuhan, 430033, China
Xinxiang Central Hospital
Xinxiang, 453000, China
The People's Hospital Of Xuancheng City
Xuancheng, 242000, China
Xuzhou Central Hospital
Xuzhou, 221009, China
Yantai Yuhuangding Hospital
Yantai, 264000, China
Yulin First People's Hospital
Yulin, 537000, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, 363000, China
Zhengzhou Central Hospital
Zhengzhou, 450007, China
Zigong No. 1 People's Hospital
Zigong, 643000, China
University General Hospital of Alexandroupolis
Alexandroupoli, 681 00, Greece
Athens Euroclinic S.A.
Athens, 115 21, Greece
Athens Naval Hospital
Athens, 115 21, Greece
Eginitio Hospital
Athens, 11528, Greece
General Hospital of Athens "Alexandra"
Athens, 11528, Greece
University General Hospital Attikon
Athens, 12462, Greece
Metropolitan Hospital
Athens, Neo Faliro, 185 47, Greece
University General Hospital of Heraklion
Heraklion, 715 00, Greece
University General Hospital of Larissa
Larissa, 411 10, Greece
General University Hospital of Patras
Pátrai, 265 04, Greece
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 546 36, Greece
Hippokration General Hospital of Athen
Thessaloniki, 546 42, Greece
General Hospital Of Thessaloniki Papageorgiou
Thessaloniki, 564 29, Greece
Semmelweis University
Budapest, 1083, Hungary
Budapesti Uzsoki Utcai Korhaz
Budapest, 1145, Hungary
Pest Megyei Flor Ferenc Hospital
Kistarcsa, 2143, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Nyíregyháza, 4400, Hungary
University of Pecs
Pécs, 7623, Hungary
University of Szeged
Szeged, 6725, Hungary
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Zydus Hospital - Ahmedabad
Ahmedabad, 380054, India
Bangalore Medical College
Bangalore, 560002, India
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
Belagavi, 590010, India
SUM Ultimate Medicare
Bhubaneswar, 751003, India
S.P. Medical College & Associated Group of Hospitals
Bikaner, 334 003, India
Malabar Institute of Medical Sciences Ltd.
Calicut, 673016, India
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012, India
K.G. Hospital and Post Graduate Medical Institute
Coimbatore, 641018, India
North Bengal Medical College and Hospital
Darjeeling, 734 012, India
Max Super Speciality Hospital, Dehradun
Dehradun, 248001, India
Shri Mahant Indiresh Hospital
Dehradun, 248001, India
GGS Medical College & Hospital
Farīdkot, 151203, India
Max Super Speciality Hospital, Vaishali
Ghaziabad, 201012, India
Yashoda Medicity
Ghaziabad, 201014, India
Government General Hospital Guntur
Guntur, 522001, India
Lalitha PVS Institute of Medical Sciences
Guntur, 522001, India
Lalitha Super Speciality Hospital
Guntur, 522001, India
Karnataka Institute of Medical Sciences, Hubli
Hubli, 580021, India
Glenfield Mallareddy Brain Heart Hospital
Hyderabad, 500001, India
Renova Century Hospital - Banjara Hills
Hyderabad, 500028, India
Nizam's Institute of Medical Sciences
Hyderabad, 500082, India
Yashoda Hospitals, Somajiguda
Hyderabad, 500082, India
Government Medical College Jammu
Jammu, 180016, India
Renai Medicity Multi Super Specialty Hospital
Kochi, 682 025, India
Institute of Neurosciences Kolkata
Kolkata, 700017, India
Bangur Institute of Neurosciences
Kolkata, 700025, India
Baby Memorial Hospital Kozhikode
Kozhikode, 673004, India
Christian Medical College, Ludhiana
Ludhiana, 141008, India
Chopda Medicare and Research Centre Pvt Ltd
Nashik, 422005, India
Sahyadri Superspeciality Hospital, Nashik
Nashik, 422011, India
Vijaya Super Speciality Hospital
Nellore, 524001, India
BLK-Max Super Speciality Hospital, Delhi
New Delhi, 110005, India
Max Super Speciality Hospital
New Delhi, 110017, India
All India Institute of Medical Sciences, New Dehli
New Delhi, 110029, India
Dr. Ram Manohar Lohia Hospital
New Delhi, 1100o1, India
Government Medical College, Ongole
Ongole, 523001, India
Indira Gandhi Institute of Medical Sciences
Patna, 800014, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, 411004, India
Synergy Superspeciality Hospital
Rajkot, 360005, India
Great Eastern Medical School
Rāgolu, 532484, India
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak, 124001, India
Indira Gandhi Medical College & Hospital
Shimla, 171001, India
Unity Hospital
Surat, 395010, India
Bhaktivedanta Hospital & Research Institute
Thane, 401107, India
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Thiruvananthapuram, 695011, India
City Neurology Centre
Varanasi, 221002, India
Christian Medical College, Vellore
Vellore, 632004, India
Government Siddhartha Medical College
Vijayawada, 520008, India
Visakha Institute of Medical Sciences
Visakhapatnam, 530040, India
Government Medical College Vizianagaram
Vizianagaram, 535002, India
Acharya Vinobha Bhave Rural Hospital
Wardha, 442004, India
Siloam Hospitals Denpasar
Badung, 80361, Indonesia
Immanuel Hospital Bandung
Bandung, 40233, Indonesia
Dr. Cipto Mangunkusumo Hospital
Jakarta, 10430, Indonesia
Siloam Hospitals Kebon Jeruk
Jakarta, 11530, Indonesia
Siloam Hospitals TB Simatupang
Jakarta, 12430, Indonesia
Mahar Mardjono National Brain Center Hospital
Jakarta, 13630, Indonesia
Siloam Hospitals Medan
Medan, 20212, Indonesia
RSUP Dr. M. Djamil
Padang, 25171, Indonesia
RSUP Dr. Kariadi
Semarang, 50231, Indonesia
Airlangga University Hospital
Surabaya, 60115, Indonesia
Siloam Hospitals Lippo Village
Tangerang, 15811, Indonesia
Bethesda Hospital
Yogyakarta, 55223, Indonesia
RS Akademik UGM
Yogyakarta, 55291, Indonesia
Sardjito Hospital
Yogyakarta, Indonesia
City Multidisciplinary Hospital No 2
Astana, 10000, Kazakhstan
National Coordination Center for Emergency Medicine
Astana, 10000, Kazakhstan
Hospital Pengajar UiTM Puncak Alam
Bandar Puncak Alam, 43000, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, 30450, Malaysia
Hospital Universiti Sains Malaysia
Kota Bharu, 15200, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, 15586, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
Universiti Putra Malaysia
Serdang, 43400, Malaysia
Haukeland University Hospital
Bergen, 5021, Norway
Sykehuset Ostfold HF
Grålum, 1714, Norway
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, 4011, Norway
Spitalul Clinic Județean De Urgența Arad
Arad, 310037, Romania
Spitalul Clinic Judetean de Urgenta Brasov
Brasov, 500326, Romania
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Constanța, 900591, Romania
Spitalul Judetean de Urgenta Piatra Neamt
Piatra Neamţ, 610136, Romania
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
Suceava, 720284, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, 540136, Romania
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital General Universitario Dr. Balmis
Alicante, 03010, Spain
Hospital Universitario de Cruces
Barakaldo, 48903, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Vall d'Hebron - VHIR
Barcelona, 08035, Spain
Hospital Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Germans Trias i Pujol
Barcelona, 08916, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, 17007, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Hospital Ruber Juan Bravo
Madrid, 28006, Spain
Hospital Universitario De La Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen De La Macarena
Seville, 41009, Spain
Hospital Universitari Joan XXIII
Tarragona, 43005, Spain
Hospital Universitari Mutua de Terrasa
Terrassa, 08221, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Álvaro Cunqueiro
Vigo, 36312, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Chang Gung Memorial Hospital Chiayi
Buzi, 61363, Taiwan
Changhua Christian Hospital
Changhua, 50006, Taiwan
Chang Gung Memorial Hospital-Keelung
Keelung, 204, Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 23561, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 100225, Taiwan
Taipei Veterans General Hospital
Taipei, 112201, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Thammasat University Hospital
Klong Luang, 12120, Thailand
Lampang Hospital
Lampang, 52000, Thailand
Sunprasitthiprasong Hospital
Muang, 34000, Thailand
Da Nang Hospital
Da Nang, 550000, Vietnam
Viet Tiep Hospital
Haiphong, Vietnam
Bach Mai hospital
Hanoi, 100000, Vietnam
Le Van Thinh Hospital
Ho Chi Minh City, 700000, Vietnam
Military Hospital 175
Ho Chi Minh City, 700000, Vietnam
Nguyen Tri Phuong Hospital
Ho Chi Minh City, 700000, Vietnam
Nhan Dan Gia Dinh Hospital
Ho Chi Minh City, 700000, Vietnam
People's Hospital 115
Ho Chi Minh City, 700000, Vietnam
Thong Nhat Hospital HCMC
Ho Chi Minh City, 700000, Vietnam
University Medical Center HCMC
Ho Chi Minh City, 748806, Vietnam
Phu Tho General Hospital
Viet Tri, 290000, Vietnam
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2026
First Posted
January 23, 2026
Study Start
February 17, 2026
Primary Completion (Estimated)
October 2, 2027
Study Completion (Estimated)
October 2, 2027
Last Updated
September 29, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.