Clinical trials: Surveillance
Respiratory Syncytial Virus Infection
Surveillance of Synagis in Korean Pediatric Patients
Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study.
- Trial name
- NCT01537198
- Volunteers
- 618 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Essential Hypertension
A Study for PMS of AZL-M/CLD FDC in the Treatment of Participants With Essential HTN in South Korea
The purpose of this study is to evaluate the safety by assessing all serious and non-serious adverse events (AEs), irrespective of relatedness or expectedness, as well as other safety parameters including laboratory values…
- Trial name
- NCT04470830
- Where
- South Korea
- Volunteers
- 718 people
- Sponsor
- Celltrion Pharm, Inc.
Influenza, Human
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England
This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu…
- Trial name
- NCT03278067
- Testing
- Enhanced vaccine safety surveillance
- Where
- United Kingdom
- Volunteers
- 23,939 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Infection
Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
Primary Objective: To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).
- Trial name
- NCT04843111
- Testing
- Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Peripheral Artery Disease
Prospective, Post Market Surveillance Q3-registry (POLARIS)
This is a prospective, non-randomized post market surveillance registry designed to document the clinical Performance in Routine clinical practice of the POLARIS Peripheral Vascular Self Expanding Stent System
- Trial name
- Q3-Registry (NCT02307292)
- Testing
- POLARIS Peripheral Vascular Self Expanding Stent System
- Where
- Germany
- Volunteers
- 250 people
- Sponsor
- QualiMed Innovative Medizinprodukte GmbH
Hypertension
Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease
This study is a post-marketing surveillance in Japan, and it is a local prospective, company sponsored and observational study of patient who have been treated by Adalat CR for hypertension with diabetes and/or chronic kidney…
- Trial name
- NCT01363336
- Testing
- Nifedipine (Adalat CR, BAYA1040)
- Where
- Japan
- Volunteers
- 1,882 people
- Sponsor
- Bayer
Dengue
An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Brazil
The purpose of this study is to estimate the incidence of dengue infection in children and adults in geographically distinct locations of Brazil.
- Trial name
- NCT01751139
- Testing
- Blood sample collection, Data collection
- Where
- 5 sites in Brazil
- Volunteers
- 3,300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Angina, Chronic Coronary Occlusion
XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan
The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the…
- Conditions
- Angina, Chronic Coronary Occlusion, Stent Thrombosis, Vascular Disease
- Trial name
- NCT01086228
- Testing
- XIENCE V / PROMUS stent
- Where
- 47 sites in Japan
- Volunteers
- 2,010 people
- Sponsor
- Abbott Medical Devices
Hypertension
Post Marketing Surveillance (PMS) Study to Assess Safety and Efficacy of Micardis in Patients With Essential Hypertension
The objective of this PMS study was to monitor and assess the safety of Micardis tablets in patients with hypertension over a period of 6 years
- Trial name
- NCT02245464
- Testing
- Telmisartan
- Volunteers
- 13,066 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C, Chronic, Substance Abuse, Intravenous
Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)
Previous intravenous drug abusers with chronic hepatitis C who are under substitution therapy (buprenorphine, methadone) will be treated with PegIntron and Rebetol according to the approved European labeling.
- Trial name
- SUPPORT (NCT00726557)
- Testing
- PegIntron (pegylated interferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Volunteers
- 246 people
- Sponsor
- Merck Sharp & Dohme LLC
Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal
Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study
The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the Pinnacle Acetabular MoM system.
- Conditions
- Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal, Adverse Local Tissue Reaction, Metal Ions
- Trial name
- NCT01828801
- Testing
- Pinnacle Metal-on Metal
- Where
- 8 sites in United States
- Volunteers
- 276 people
- Sponsor
- DePuy Orthopaedics
Mucopolysaccharidosis I
China Post-marketing Surveillance (PMS) Study of Aldurazyme®
This is a single treatment arm study that is open-label to be conducted in Chinese participants with MPS I. Trial Objectives are to evaluate the safety and tolerability of Aldurazyme in Chinese MPS I participants, and to evaluate…
- Trial name
- NCT05134571
- Testing
- Laronidase
- Where
- 5 sites in China
- Volunteers
- 12 people
- Sponsor
- Genzyme, a Sanofi Company
Carcinoma, Renal Cell
Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program
This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or…
- Trial name
- NCT01412671
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- Japan
- Volunteers
- 117 people
- Sponsor
- Bayer
Hypertension, Dyslipidemias
Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy
Post-marketing surveillance of Telostop TAB (Telmisartan/Rosuvastatin)
- Trial name
- NCT03742544
- Volunteers
- 600 people
- Sponsor
- IlDong Pharmaceutical Co Ltd
Diabetes, Diabetes Mellitus, Type 1
A Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India
This study is conducted in Asia. The aim of the study is to evaluate long term safety and efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine clinical practice in India.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT02117622
- Testing
- insulin degludec
- Where
- 38 sites in India
- Volunteers
- 1,056 people
- Sponsor
- Novo Nordisk A/S
Neoplasms, Squamous Cell
A Post-marketing Surveillance Study on Erbitux in Combination With Platinum-based Chemotherapy in Metastatic/Recurrent Squamous Cell Cancer of the Head and Neck
This is a prospective post-marketing surveillance (PMS) study to collect safety information from more than 600 subjects with recurrent and/or metastatic squamous cell cancer of the head and neck (SCCHN) treated with Erbitux as…
- Trial name
- NCT01075841
- Testing
- Cetuximab
- Sponsor
- Merck KGaA, Darmstadt, Germany
Intra-Abdominal Infections, Skin Disease, Infectious
Tygacil Drug Use Investigation
Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice
- Trial name
- TIGER (NCT01789905)
- Testing
- Tigecycline (Tygacil)
- Volunteers
- 116 people
- Sponsor
- Pfizer
Menorrhagia, Dysmenorrhea
Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea
The primary objective in this study is collecting post-marketing information on the safety. Thus, it includes information under the routine clinical practice on adverse events (AEs) and adverse drug reactions (ADRs) including…
- Trial name
- J-MIRAI (NCT02475356)
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028)
- Where
- Japan
- Volunteers
- 601 people
- Sponsor
- Bayer
Myocardial Infarction
Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Early Inhospital Thrombolysis With Metalyse
Obtaining data on efficacy (e.g. complete ST-segment resolution) depending on the time of treatment initiation and safety of prehospital and early hospital thrombolysis with Metalyse® in a real life setting outside clinical…
- Trial name
- NCT02194153
- Testing
- Metalyse weight-adjusted
- Volunteers
- 351 people
- Sponsor
- Boehringer Ingelheim
Hepatocellular Carcinoma
Imjudo & Imfinzi PMS
Based on the re-review of new drugs article, Korean pharmaceutical act, the objectives of this study are to assess safety and effectiveness of the study drugs(Imjudo \& Imfinzi) in a real world setting in patients who treated…
- Trial name
- NCT06544629
- Where
- 6 sites in South Korea
- Volunteers
- 246 people
- Sponsor
- AstraZeneca
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