Clinical trials: PMS
Rhinitis, Allergic, Perennial and Seasonal
Regulatory AVAMYS Nasal Spray PMS
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients according to the prescribing information.
- Trial name
- NCT01001130
- Testing
- fluticasone furoate group
- Where
- South Korea
- Volunteers
- 3,244 people
- Sponsor
- GlaxoSmithKline
Unresectable Hepatocellular Carcinoma
Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
This investigation will be conducted to collect information of safety in patients with unresectable hepatocellular carcinoma (HCC) treated with the combination therapy of IMJUDO 25 mg, 300 mg and IMFINZI Intravenous Infusion 120…
- Trial name
- NCT05667064
- Volunteers
- 1,200 people
- Sponsor
- AstraZeneca
Prevention of Infectious Disease Caused by SARS-CoV-2
VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Long-term Safety of VAXZEVRIA
This survey will be conducted for the subjects who participate in the priority survey (cohort survey) conducted by the Scientific Research Group of the Ministry of Health, Labour and Welfare at the initial stage of administration…
- Trial name
- NCT05135455
- Where
- 6 sites in Japan
- Volunteers
- 467 people
- Sponsor
- AstraZeneca
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
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
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
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
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
Skin Infections, Bacterial
ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)
This is an open label, multi-centre, non-interventional post-marketing surveillance.
- Trial name
- ALTARGOPMS (NCT01445600)
- Testing
- ALTARGO(retapamulin)
- Where
- South Korea
- Volunteers
- 3,612 people
- Sponsor
- GlaxoSmithKline
Cancer
Regulatory TYKERB® Tablets PMS
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information TYKERB® is…
- Trial name
- NCT00975988
- Testing
- TYKERB® tablets
- Where
- 2 sites in South Korea
- Volunteers
- 750 people
- Sponsor
- GlaxoSmithKline
Angina, Coronary Occlusion
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and…
- Conditions
- Angina, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis
- Trial name
- NCT01721096
- Testing
- XIENCE PRIME - Long Length (LL), XIENCE PRIME - Core Size
- Where
- Japan
- Volunteers
- 536 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis, Aortic Valve Stenosis
SAPIEN 3 Ultra EU PMS
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating…
- Trial name
- NCT04860752
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 37 sites in Austria, Finland and 8 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Pulmonary Disease, Chronic Obstructive
Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease
Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting
- Trial name
- NCT02850978
- Testing
- Spiolto
- Where
- Japan
- Volunteers
- 1,335 people
- Sponsor
- Boehringer Ingelheim
Breast Cancer
LYNPARZA Breast Cancer in the Adjuvant Setting Japan Post-Marketing Surveillance (PMS)
To evaluate the frequency of bone marrow suppression Adverse Drug Reactions (ADRs) in patients with BRCA mutated HER2 negative high recurrent risk breast cancer treated with LYNPARZA for adjuvant treatment in the actual…
- Trial name
- NCT05677308
- Where
- 38 sites in Japan
- Volunteers
- 61 people
- Sponsor
- AstraZeneca
Prevention of Infectious Disease Caused by SARS-CoV-2
VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Subjects With Underlying Disease at High-risk for Worsening COVID-19
To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance…
- Trial name
- NCT05084755
- Where
- 3 sites in Japan
- Volunteers
- 4 people
- Sponsor
- AstraZeneca
Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck, LA SCCHN
A Post Marketing Surveillance Study to Assess the Safety and Efficacy of Cetuximab Plus Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
This prospective, observational, multicentre, post marketing surveillance study will collect safety and efficacy information on patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN) treated with…
- Trial name
- PMS LAD SCCHN (NCT01303237)
- Testing
- Cetuximab + RT
- Where
- 25 sites in India
- Volunteers
- 88 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Benign Prostatic Hyperplasia, Prostatic Hyperplasia
AVODART(Dutasteride) Post-marketing Surveillance(PMS)
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVODART administered in Korean BPH patients according to the prescribing information
- Trial name
- AVO PMS (NCT01299571)
- Testing
- Dutasteride
- Where
- South Korea
- Volunteers
- 3,977 people
- Sponsor
- GlaxoSmithKline
Infection, Human Immunodeficiency Virus I
ZIAGEN® Post-marketing Surveillance
An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and efficacy of ZIAGEN® administered in Korean patients according to the prescribing information.
- Trial name
- NCT01205243
- Testing
- ZIAGEN®
- Where
- South Korea
- Volunteers
- 671 people
- Sponsor
- ViiV Healthcare
Diabetes, Diabetes Mellitus, Type 1
Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) in Patients With Diabetes Mellitus in Routine Clinical Practice in India
This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT02230618
- Testing
- insulin degludec/insulin aspart
- Where
- 35 sites in India
- Volunteers
- 1,029 people
- Sponsor
- Novo Nordisk A/S
Hypertension, Heart Failure
Regulatory Nebilet PMS
An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebivolol administered in Korean patients according to the prescribing information
- Trial name
- Nebilet PMS (NCT01077661)
- Testing
- Nebivolol
- Where
- South Korea
- Volunteers
- 743 people
- Sponsor
- GlaxoSmithKline