Clinical trials: Korean
Poliomyelitis, Tetanus
Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine
This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.
- Conditions
- Poliomyelitis, Tetanus, Acellular Pertussis, Diphtheria
- Trial name
- NCT01309646
- Testing
- Infanrix™-IPV+Hib, Infanrix™ IPV, Hiberix™
- Where
- 11 sites in South Korea
- Volunteers
- 454 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Ulcerative Colitis
A Prospective Non-interventional Multicenter Study to Evaluate the Effectiveness of Adalimumab in Korean Patients With Ulcerative Colitis (UC) and Identify Potential Predictors of Clinical Response in Routine Clinical Practice
This is a prospective, single country, multi-center study in participants with ulcerative colitis (UC) treated with adalimumab. Up to 147 participants are enrolled at approximately 20 sites.
- Trial name
- EUREKA (NCT02499263)
- Where
- 19 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- AbbVie
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
Hepatitis B, Chronic, Chronic Hepatitis B
Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
This is an open label, single-arm, multi-centre extension study for Korean patients with chronic hepatitis B and compensated liver disease who have completed one-year adefovir dipivoxil treatment in ADF103814.
- Trial name
- NCT00403585
- Testing
- adefovir dipivoxil 10mg
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- GlaxoSmithKline
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)
Dyslipidemia, Hypercholesterolemia
A Study to Evaluate Fasting/Postprandial Serum Apolipoprotein B-48 (ApoB-48) Levels in Diabetic Participants With Normal to Moderately High Low Density Lipoprotein-C (LDL-C) Levels (MK-0653A-259 AM1)
This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in diabetic participants compared to nondiabetic participants with the same range of serum LDL-C levels, and whether ApoB-48 levels can be…
- Trial name
- NCT01333436
- Testing
- Test Meal
- Where
- South Korea
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Pediatric Crohn's Disease
Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"
This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea.
- Trial name
- NCT02578238
- Volunteers
- 143 people
- Sponsor
- AbbVie
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
Hematologic Malignancy
Besponsa Post Marketing Surveillance Study
Besponsa is approved for the treatment of R/R B-cell ALL in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS.
- Trial name
- NCT04307134
- Testing
- Inotuzumab ozogamicin
- Where
- South Korea
- Volunteers
- 108 people
- Sponsor
- Pfizer
Pain
A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone Controlled Release (CR)) in Japanese and Korean…
- Trial name
- NCT01165281
- Testing
- Oxycodone CR, R331333 (referred to as JNS024 ER or CG5503)
- Where
- 52 sites in Japan, South Korea
- Volunteers
- 343 people
- Sponsor
- Janssen Research & Development, LLC
Rheumatoid Arthritis
A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate after 6 months (Day 169) of treatment in Korean…
- Trial name
- NCT00409838
- Testing
- Abatacept, Methotrexate
- Where
- 7 sites in South Korea
- Volunteers
- 113 people
- Sponsor
- Bristol-Myers Squibb
Cataract, Presbyopia
Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Intraocular Lens (IOL) in a Korean Population
The purpose of this study is to confirm the effectiveness of the investigational lens in a Korean population, especially for visual performance, quality of vision, and subject satisfaction with the visual outcome, as well as the…
- Trial name
- NCT03268746
- Testing
- AcrySof IQ PanOptix Multifocal IOL
- Where
- 4 sites in South Korea
- Volunteers
- 52 people
- Sponsor
- Alcon Research
Nausea, Vomiting
A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC)
This is an efficacy and safety study to compare aprepitant with ondansetron for the prevention of nausea and vomiting in the first cycle of moderately emetogenic chemotherapy (MEC) in participants with solid tumors.
- Trial name
- KMEC (NCT01636947)
- Testing
- Aprepitant, Ondansetron, Dexamethasone
- Volunteers
- 494 people
- Sponsor
- Merck Sharp & Dohme LLC
Neuromuscular Blockade
Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)
This is a randomized, active-controlled, parallel-group, single-dose, multi-site, safety-assessor blinded study comparing sugammadex to neostigmine for reversal of neuromuscular blockade in Korean subjects undergoing elective…
- Trial name
- DANCHEONG (NCT01050543)
- Testing
- sugammadex, neostigmine
- Volunteers
- 128 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Tourette's Disorder
ABF Tourette's Disorder Post Marketing Surveillance Study
This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA Notification No. 2010-94 dated 27 December 2010).
- Trial name
- NCT01795105
- Where
- 4 sites in South Korea
- Volunteers
- 692 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Measles, Mumps
A Study of ProQuad™ in Healthy Children in Korea (V221-023)
This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability.
- Conditions
- Measles, Mumps, Rubella, Varicella
- Trial name
- NCT00839917
- Testing
- Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™), M-M-R™ II and Varivax™
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Epilepsy, Neuropathic Pain
Lyrica (Pregabalin) Korean Post Marketing Surveillance Study
This study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in Korea.
- Conditions
- Epilepsy, Neuropathic Pain, Fibromyalgia, Post-market Surveillance
- Trial name
- NCT01220180
- Testing
- pregabalin (Lyrica)
- Volunteers
- 4,175 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Spinal Disorder
An Interventional Study to Assess the Efficacy and Safety of Buprenorphine in Korean Patients With Spinal Disorders
The purpose of this study is to assess the pain reduction rate after 8 weeks treatment of NORSPAN® from baseline. And secondary purpose are: pain reduction rate after 4 weeks treatment from baseline(week 0) the EQ-5D, the pain…
- Trial name
- NOBLE (NCT01818700)
- Testing
- Buprenorphine
- Where
- South Korea
- Volunteers
- 245 people
- Sponsor
- Mundipharma Korea Ltd