Clinical trials: Korean
Poliomyelitis
A Post-marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children
Following licensing of PoliorixTM in Korea, this study will collect safety data about the routine use of this vaccine in 600 children according to the regulations of Korean Food and Drugs Administration (KFDA).
- Trial name
- NCT00514033
- Testing
- Poliomyelitis vaccine (inactivated) -PoliorixTM
- Where
- South Korea
- Volunteers
- 349 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteer
PK/PD, Safety and Tolerability of PHP-201 Topical Eye Drop in Korean and Japanese Healthy Subjects
An open label, multiple-dose, phase 1 clinical trial to evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of PHP-201 topical eye drop in Korean and Japanese healthy subjects
- Trial name
- NCT03586908
- Testing
- PHP-201 0.5% ophthalmic solution (topical eye drop)
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- pH Pharma
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)
Colitis, Ulcerative
A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants
The purpose of this study is to assess the clinical effectiveness by the clinical response at 6 weeks and the safety of vedolizumab intravenous in UC Korean participants.
- Trial name
- NCT03535649
- Where
- 15 sites in South Korea
- Volunteers
- 105 people
- Sponsor
- Takeda
Myocardial Infarction
Post Marketing Surveillance to Monitor the Safety and Efficacy of Metalyse® in Korean Patients With Acute Myocardial Infarction
To monitor the safety of Metalyse® in clinical practice in patients with acute myocardial infarction over a period of 6 years as required by Korean authorities, with the following observations: 1.
- Trial name
- NCT02206646
- Testing
- Metalyse
- Volunteers
- 987 people
- Sponsor
- Boehringer Ingelheim
Type 2 Diabetes Mellitus, Hypercholesterolemia
Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia
To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia
- Trial name
- NCT03446261
- Testing
- Rosuvamibe® Tab, Monorova® Tab
- Where
- 2 sites in South Korea
- Volunteers
- 140 people
- Sponsor
- Yuhan Corporation
Osteoarthritis
A Study of the Tolerability of Titrated Dose Tramadol/Acetaminophen Combination Tablet in Korean Patients With Osteoarthritis
The purpose of this study is to compare the number of osteoarthritis patients receiving titrated or increasing doses of tramadol hydrochloride/acetaminophen combination tablet (titration group) who discontinue treatment due to…
- Trial name
- NCT01063842
- Testing
- tramadol hydrochloride /acetaminophen
- Volunteers
- 250 people
- Sponsor
- Janssen Korea, Ltd., Korea
Prostate Cancer
Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients
This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean patients with prostate cancer.
- Trial name
- NCT01215513
- Testing
- Degarelix
- Where
- 11 sites in South Korea
- Volunteers
- 127 people
- Sponsor
- Ferring Pharmaceuticals
Diabetes Mellitus, Type 2
A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea
The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.
- Trial name
- NCT01903356
- Testing
- Trajenta duo
- Where
- South Korea
- Volunteers
- 724 people
- Sponsor
- Boehringer Ingelheim
PNH
Observational of PNH Type Cells in Korean Patients With Bone Marrow Failure Syndrome and Having Hemolytic PNH
Patients who are positive of PNH-type cells are followed up for the percentage of PNH-type cells regularly for examining how it change.
- Trial name
- OPENK (NCT03460301)
- Volunteers
- 233 people
- Sponsor
- Handok Inc.
IgA Nephropathy
A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients
This study is to evaluate efficacy and safety of tacrolimus in the patients with non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with tacrolimus (Prograf) or placebo.
- Trial name
- NCT01224028
- Testing
- Tacrolimus
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Astellas Pharma Inc
Diabetes Mellitus, Type 2
Korean Post-marketing Surveillance for Onglyza®
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Onglyza® so that the regulatory…
- Trial name
- NCT01575483
- Testing
- No Intervention (subjects were previously treated with Onglyza®)
- Where
- South Korea
- Volunteers
- 3,433 people
- Sponsor
- AstraZeneca
Infertility
A Study on Efficacy and Safety of Menopur® Multidose in Korean Female Patients With Infertility
The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after embryo transfer in patients treated with Menopur® Multidose
- Trial name
- NCT02835469
- Testing
- Menotrophin
- Where
- South Korea
- Volunteers
- 412 people
- Sponsor
- Ferring Pharmaceuticals
Bipolar Disorder
Lamictal Bipolar Observational Study
This is multi-center, prospective, observational stud. This study is designed to evaluate the rate of non-serious rash in Korean bipolar I patients.
- Trial name
- NCT00460226
- Testing
- lamotrigine
- Volunteers
- 238 people
- Sponsor
- GlaxoSmithKline
Colorectal Neoplasms
A Korean Post-marketing Surveillance Study on Erbitux® in Patients With Metastatic Colorectal Cancer Refractory to Irinotecan-containing Treatment
After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551.
- Trial name
- NCT01082315
- Testing
- Erbitux (Cetuximab)
- Where
- South Korea
- Volunteers
- 730 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Attention Deficit Hyperactivity Disorder
Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
The purpose of this study is to provide information regarding the relative effectiveness of three different atomoxetine doses in the treatment of Korean children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)
- Trial name
- NCT00568685
- Testing
- Atomoxetine Hydrochloride
- Where
- 3 sites in South Korea
- Volunteers
- 153 people
- Sponsor
- Eli Lilly and Company
Diphtheria, Tetanus
DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b Infection
- Trial name
- NCT02094833
- Testing
- DTaP-IPV-Hep B-PRP~T combined vaccine, DTaP-IPV//PRP~T and Hepatitis B vaccine
- Where
- 16 sites in South Korea
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diabetes Mellitus
A Pharmacokinetic Study of CJ30001 and HKB0701/SLM0807 in Healthy Subject
The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to healthy subjects.
- Trial name
- NCT01370681
- Testing
- Period I : HKB0701 and SLM0807, Period II : CJ30001, Period I : CJ30001, Period II : HKB0701 and SLM0807
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Chronic Heart Failure
Association Between Genetic Polymorphism of Beta-adrenergic Receptor and Effects of Bisoprolol in Korean Heart Failure Patients.
At present, there is some clinical data for different functional response to beta-blockers associated with beta-adrenergic receptor polymorphisms.
- Trial name
- ABBA (NCT01104558)
- Testing
- Bisoprolol
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy
Evaluating the Bioequivalence of HIP1302, HGP1406
The purpose of this study is to investigate the bioequivalence after administration of HIP1302 and HGP1406 in healthy male volunteers.
- Trial name
- NCT02545829
- Testing
- HIP1302, HGP1406
- Where
- South Korea
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited