Clinical trials: Surveillance
Hypervolemic and Euvolemic Hyponatremia
Samsca Post Marketing Surveillance Study
This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011~31Aug2017).
- Trial name
- Samsca PMS (NCT02722863)
- Where
- 4 sites in South Korea
- Volunteers
- 908 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Rheumatoid Arthritis
A Study of Rheumatoid Arthritis Patients on Adalimumab to Evaluate Quality of Life Variables, Effects on Work Productivity and Functional Outcomes in Malaysia
An observational, non-interventional study on social, economic and quality-of-life outcomes of Adalimumab use in participants with moderate to severe active Rheumatoid Arthritis.
- Trial name
- RELIVE (NCT01387789)
- Where
- 13 sites in Malaysia
- Volunteers
- 71 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Hemophilia B
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
To provide safety and effectiveness information of BeneFIX during the post-marketing period as required by Korea FDA regulations, to identify any potential drug related treatment factors in Korean population including: 1) Unknown…
- Trial name
- NCT00484185
- Testing
- BeneFIX (coagulation factor IX (recombinant))
- Where
- South Korea
- Volunteers
- 183 people
- Sponsor
- Pfizer
Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other
Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"
The purpose of this study is to evaluate the safety and efficacy on participants receiving first-line eradication and second-line eradication including vonoprazan (Takecab) tablets (triple therapy) in the routine clinical setting.
- Trial name
- NCT03219723
- Testing
- Vonoprazan, Amoxicillin hydrate, Clarithromycin
- Where
- Japan
- Volunteers
- 560 people
- Sponsor
- Takeda
Diabetes Mellitus, Type 2
Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus
This is a prospective, non-interventional, open label, multi center, post marketing surveillance study designed to assess the safety, tolerability and efficacy of Linagliptin among Filipino patients with type 2 Diabetes Mellitus…
- Trial name
- NCT01826370
- Testing
- Linagliptin
- Where
- 51 sites in Philippines
- Volunteers
- 678 people
- Sponsor
- Boehringer Ingelheim
Overactive Bladder (OAB)
Drug Use Investigation for Toviaz
The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.
- Trial name
- NCT01936870
- Testing
- Fesoterodine (Toviaz)
- Volunteers
- 2,521 people
- Sponsor
- Pfizer
Diphtheria, Tetanus
Regulatory Post-Marketing Surveillance Study for TETRAXIM™
The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT01437423
- Testing
- TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
- Where
- South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Gastric or Duodenal Ulcers
Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin
The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin
- Trial name
- NCT02099682
- Testing
- Lansoprazole
- Volunteers
- 3,366 people
- Sponsor
- Takeda
Premenopausal Breast Cancer
Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
- Trial name
- NCT03209518
- Testing
- Leuprorelin acetate
- Where
- Japan
- Volunteers
- 312 people
- Sponsor
- Takeda
Heart Failure
Jardiance® Post Marketing Surveillance (PMS) in Korean Patients With Chronic Heart Failure
The primary objective of this study is to monitor the safety profile of Jardiance® in Korean patient with chronic heart failure (New York Heart Association (NYHA) class II-IV) in a routine clinical setting.
- Trial name
- NCT05236673
- Testing
- JARDIANCE®
- Where
- 21 sites in South Korea
- Volunteers
- 676 people
- Sponsor
- Boehringer Ingelheim
Osteoporosis
Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
This survey is conducted for preparing application material for re examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and efficacy profiles of VIVIANT in usual practice…
- Trial name
- NCT01793142
- Testing
- Viviant
- Where
- 60 sites in South Korea
- Volunteers
- 3,430 people
- Sponsor
- Pfizer
Diabetes Mellitus, Type 2
Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus
Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
- Trial name
- NCT02367131
- Testing
- JARDIANCE®
- Where
- Japan
- Volunteers
- 419 people
- Sponsor
- Boehringer Ingelheim
Polyarticular Juvenile Idiopathic Arthritis
Surveillance of Humira in Korean JIA Patients
Approximately 600 pediatric patients prescribed Humira Injection in usual practice according to the approved Korean product label will be registered into this observational study.
- Trial name
- NCT02141984
- Volunteers
- 28 people
- Sponsor
- AbbVie
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)
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
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
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
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
Colorectal Cancer
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.
- Trial name
- NCT01694966
- Testing
- Methylene Blue MMX®
- Where
- 19 sites in United States, Belgium and 6 more
- Volunteers
- 1,249 people, healthy volunteers welcome
- Sponsor
- Cosmo Technologies Ltd