Clinical trials: Surveillance
Atrial Fibrillation
Japanese Pradaxa PMS, Long Term
The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab
- Trial name
- NCT03175198
- Testing
- Prazaxa® Capsules
- Where
- Japan
- Volunteers
- 5,660 people
- Sponsor
- Boehringer Ingelheim
Multiple Sclerosis, Relapsing-remitting
A Study for Tecfidera (Dimethyl Fumarate) Capsules in Korean Participants With Relapsing-Remitting Multiple Sclerosis
The primary purpose of this study is to evaluate the overall safety and efficacy of Tecfidera (Dimethyl Fumarate) as an oral treatment for Korean participants with relapsing-remitting multiple sclerosis (MS) under routine…
- Trial name
- NCT05366036
- Testing
- No Intervention
- Where
- 20 sites in South Korea
- Volunteers
- 172 people
- Sponsor
- Eisai Korea Inc.
Breast Reconstruction, Mammary Reconstruction
A Clinical Study Evaluating the Safety and Performance of Eurosilicone Integrated Valve Tissue Expanders (IVTE)
Patients can undergo breast reconstruction surgery in two stages before implantation of the permanent prosthesis for several reasons.
- Trial name
- NCT07842406
- Testing
- Breast reconstruction surgery
- Volunteers
- 100 people
- Sponsor
- GCA (Eurosilicone)
Chronic Constipation
A Post Marketing Surveillance Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation
The purpose of this study is to determine the safety and effectiveness of prucalopride in the treatment of Filipino patients with chronic constipation whom prior laxatives fail to provide adequate relief.
- Trial name
- NCT01692132
- Testing
- Prucalopride
- Where
- 7 sites in Philippines
- Sponsor
- Janssen Pharmaceutica
Hypertension
Post-Marketing Surveillance of Micardis® (Telmisartan) in Patients With Hypertension
The primary objective of this survey is to prospectively investigate safety and efficacy in patients with hypertension treated with telmisartan in proper use in medical practice over a long period
- Trial name
- NCT02242838
- Testing
- Telmisartan
- Volunteers
- 6,336 people
- Sponsor
- Boehringer Ingelheim
Pneumococcal Disease
Study Evaluating Prevenar in High-Risk Children
The purpose of this study is to estimate the local and systemic tolerability of Prevenar in children ages 2 to 5 years old in usual care settings.
- Trial name
- NCT00234338
- Where
- Germany
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Non-Hodgkin's Lymphoma (NHL)
Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan
This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess biodistribution of the Zevalin.
- Trial name
- ZEVALIN-SDUI (NCT01479387)
- Testing
- [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)
- Where
- Japan
- Volunteers
- 72 people
- Sponsor
- Bayer
Pulmonary Disease, Chronic Obstructive
Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease
The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions…
- Trial name
- NCT02232594
- Testing
- Berodual®
- Volunteers
- 834 people
- Sponsor
- Boehringer Ingelheim
Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting.
- Trial name
- LSS of 4-SITE (NCT01596595)
- Where
- 111 sites in United States, Australia and 1 more
- Volunteers
- 1,820 people
- Sponsor
- Boston Scientific Corporation
NSCLC
Post-Market Surveillance Study of ALK-Positive Advanced NSCLC Participants Treated With Iruplinalkib
The goal of this observational study is to evaluate the safety and efficacy of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with…
- Trial name
- NCT06644495
- Volunteers
- 1,000 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Advanced Heart Failure
Hong Kong and Taiwan HM3 PMS
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04703855
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 3 sites in Hong Kong, Taiwan
- Volunteers
- 3 people
- Sponsor
- Abbott Medical Devices
Infertility
A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
This prospective study collected safety information from more than 600 participants treated with Pergoveris®. During the Post-Marketing Surveillance (PMS) period, data about the participant's background, participant's medical…
- Trial name
- NCT01416987
- Testing
- Pergoveris®
- Where
- 2 sites in South Korea
- Volunteers
- 600 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Fabry Disease
China Post-marketing Surveillance (PMS) Study of Fabrazyme®
This is a 54-week Phase 4, open label, single arm study to evaluate the safety and the efficacy of Fabrazyme (agalsidase beta) as enzyme replacement therapy (ERT) in Chinese participants with Fabry Disease.
- Trial name
- NCT05054387
- Testing
- Agalsidase beta
- Where
- 6 sites in China
- Volunteers
- 22 people
- Sponsor
- Genzyme, a Sanofi Company
Osteoarthritis, Hip, Rheumatoid Arthritis
Avenir Müller Hip Stem Post Market Surveillance Study
This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2.
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis, Fracture of Hip, Dislocated Hip
- Trial name
- NCT04079127
- Testing
- Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.
- Volunteers
- 150 people
- Sponsor
- Zimmer Biomet
Screening Colonoscopy, Surveillance Colonoscopy
Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.
This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.
- Trial name
- NCT06568523
- Testing
- MAGENTIQ-COLO.
- Where
- 5 sites in United States, Israel and 1 more
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Magentiq Eye LTD
Neovascular Age-related Macular Degeneration
Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.
An open label, non-comparative, multicenter, non-interventional, post marketing surveillance study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the treatment of Filipino patients with…
- Trial name
- NCT00820742
- Testing
- Macugen
- Sponsor
- Pfizer
Peripheral Vascular Disease, Hemorrhage
The Evicel Post-Authorization Surveillance Study
The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.
- Trial name
- NCT01158261
- Testing
- EVICEL ™ Fibrin Sealant (Human)
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Ethicon, Inc.
Hepatitis C
Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the safety and efficacy of SOF administered in…
- Trial name
- NCT02562742
- Testing
- SOF, REB
- Where
- 45 sites in Japan
- Volunteers
- 554 people
- Sponsor
- Gilead Sciences
Hemophilia A
Drug Use Investigation of Kovaltry in Hemophilia A Patients
The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.
- Trial name
- 18706 (NCT02941783)
- Testing
- Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
- Volunteers
- 230 people
- Sponsor
- Bayer
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Tresiba®
This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in patients with diabetes mellitus requiring insulin…
- Trial name
- NCT01984372
- Testing
- insulin degludec
- Where
- Japan
- Volunteers
- 6,163 people
- Sponsor
- Novo Nordisk A/S
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