Clinical trials: Surveillance
Hypertension
Post Marketing Surveillance Study in Rehabilitation Clinics (Cardio, Nephro, Diabetes, Pulmo)
Study to obtain long-term data on effects, safety and tolerability in routine medical practice and to investigate the potential of telmisartan to prevent secondary organ damage
- Trial name
- NCT02262611
- Testing
- Micardis®, MicardisPlus®
- Volunteers
- 266 people
- Sponsor
- Boehringer Ingelheim
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.
Insomnia
Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.
- Trial name
- NCT02058992
- Testing
- Ramelteon
- Volunteers
- 3,339 people
- Sponsor
- Takeda
Carcinoma, Hepatocellular
A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Participants With Unresectable Hepatocellular Carcinoma
This study is a post-marketing observational study of lenvatinib in participants with unresectable hepatocellular carcinoma. The primary objective of this study is assessment of risk factors for hepatic encephalopathy.
- Trial name
- NCT03663114
- Testing
- Lenvatinib
- Where
- 2 sites in Japan
- Volunteers
- 713 people
- Sponsor
- Eisai Inc.
Muscular Atrophy, Spinal
Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection
The primary objective of this study is to evaluate the safety of nusinersen sodium injection in the postmarketing setting in China.The secondary objectives are to collect data on the efficacy and the pharmacokinetics of…
- Trial name
- PANDA (NCT04419233)
- Testing
- Nusinersen Sodium Injection
- Where
- 9 sites in China
- Volunteers
- 50 people
- Sponsor
- Biogen
Osteoporosis
Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)
The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as to examine "the status of treatment compliance" …
- Trial name
- NCT02089997
- Testing
- Sodium Risedronate
- Where
- 2 sites in Japan
- Volunteers
- 3,304 people
- Sponsor
- Takeda
Multiple Myeloma, Myelodysplastic Syndromes
A Study of Special Use Results Surveillance of Revlimid 5mg Capsules
To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval. 1.
- Trial name
- NCT02921802
- Where
- Japan
- Volunteers
- 4,626 people
- Sponsor
- Celgene
Type 2 Diabetes Melitus
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"
The purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to…
- Trial name
- NCT01945242
- Testing
- Alogliptin
- Volunteers
- 1,374 people
- Sponsor
- Takeda
Pneumococcal Disease
Post Market Surveillance to Observe Safety of Prevenar13™ in Adults
The purpose of this study is to assess safety profile of Prevenar 13™ when used among Korean adults in the routine clinical setting, as required for any new drug approved by Korea Food and Drug Administration (KFDA).
- Trial name
- NCT01834222
- Testing
- Non-intervention
- Where
- 27 sites in South Korea
- Volunteers
- 659 people
- Sponsor
- Pfizer
Papillomavirus Infections
GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)
This study will collect safety information on the use of GARDASIL™ in the Philippines.
- Trial name
- NCT01355003
- Volunteers
- 1,080 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Melanoma
Yervoy Pregnancy Surveillance Study
The study is a global safety surveillance study of pregnancy outcomes in women who were exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age
- Trial name
- NCT02854488
- Testing
- Yervoy
- Where
- United States
- Sponsor
- Bristol-Myers Squibb
SARS-CoV-2
Post-Marketing Safety Study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in the United States
The goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine.
- Trial name
- NCT04958954
- Where
- United States
- Volunteers
- 50,000,000 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Yellow Fever
Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea
This is a passive enhance safety surveillance (ESS) of Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice.
- Trial name
- NCT03541694
- Testing
- Stamaril®
- Where
- South Korea
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pelvic Organ Prolapse
Xenform Postmarket Surveillance Study
To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
- Trial name
- Xenform (NCT01945580)
- Testing
- Prolapse Repair
- Where
- 25 sites in United States
- Volunteers
- 374 people
- Sponsor
- Boston Scientific Corporation
Acquired Immune Deficiency Syndrome
A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista
The purpose of this study is to assess the safety data of darunavir in a natural clinical practice.
- Trial name
- NCT01741831
- Testing
- No intervention
- Where
- South Korea
- Volunteers
- 225 people
- Sponsor
- Janssen Korea, Ltd., Korea
Pancreatic Neoplasms
LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)
To collect and characterise the incidence of adverse events related to the safety specifications of the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated pancreatic cancer under the actual…
- Trial name
- NCT04889404
- Where
- 60 sites in Japan
- Volunteers
- 130 people
- Sponsor
- AstraZeneca
Breast Neoplasms
Korea Post Marketing Surveillance (PMS) Study of Talzenna®
Talzenna will be approved for the treatment of gBRCA advanced breast cancer in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS.
- Trial name
- NCT04982848
- Testing
- Talzenna
- Sponsor
- Pfizer
COVID-19, SARS-CoV-2
Secondary Databased Post-marketing Surveillance Study of BNT162b2
This study is to assess the post-marketing safety of BNT162b2 products using nationwide population-based database in Republic of Korea.
- Trial name
- NCT06743334
- Testing
- Tozinameran (BNT162b2), Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1), Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)
- Where
- South Korea
- Volunteers
- 14,302,529 people
- Sponsor
- Pfizer
Hepatocellular Carcinoma
Post-marketing Surveillance of DC Bead in Patients With Hepatocellular Carcinoma
This surveillance's objectives are: 1. Unknown adverse reactions 2. Incidences of adverse drug reaction 3. Factors considered to have effect to safety and effectiveness
- Trial name
- NCT02269995
- Testing
- E7040
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- Eisai Co., Ltd.
Multiple Sclerosis
Controlled High Risk AVONEX® Multiple Sclerosis Prevention Study In Ongoing Neurological Surveillance
Phase IV, multi-center, non-treatment, observational, registry study to determine long term effects of AVONEX® therapy on EDSS, MRI, QoL, and cognition.
- Trial name
- CHAMPIONS CONT (NCT01156298)
- Where
- United States
- Volunteers
- 383 people
- Sponsor
- Biogen
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