Clinical trials: PMS
Advanced Heart Failure
Hong Kong and Taiwan HM3 PMS
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04703855
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 3 sites in Hong Kong, Taiwan
- Volunteers
- 3 people
- Sponsor
- Abbott Medical Devices
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
Premenstrual Syndrome, Menstruation Disturbances
Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.
- Trial name
- NCT00195559
- Testing
- Levonorgestrel/Ethinyl Estradiol
- Where
- 51 sites in Argentina, Brazil and 10 more
- Volunteers
- 526 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hepatitis B, Chronic
Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study
This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues (NAs).
- Trial name
- NCT02195518
- Testing
- Tenofovir disoproxil fumarate
- Where
- 12 sites in China
- Volunteers
- 213 people
- Sponsor
- GlaxoSmithKline
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.
Aspergillosis, Mucormycosis
Post Marketing Surveillance (PMS) Study of Cresemba in Korea.
The purpose of this study is to observe safety and effectiveness of Cresemba in patients with invasive Aspergillosis or invasive Mucormycosis in Korea during the post-marketing surveillance period as required by Ministry of Food…
- Trial name
- NCT04744454
- Testing
- Isauvuconazole group
- Where
- South Korea
- Volunteers
- 94 people
- Sponsor
- Pfizer
SARS-CoV-2
Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE
The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety-related information in South-Korean population.
- Trial name
- NCT06333704
- Testing
- SPIKEVAX Bivalent BA.1, SPIKEVAX Bivalent BA.4/5, SPIKEVAX XBB.1.5
- Where
- 26 sites in South Korea
- Volunteers
- 4,207 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Retinopathy of Prematurity
Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity
This study was an open-labeled, multicenter, single arm, observational post-marketing surveillance study under routine clinical practice with no mandated treatments, visits or assessments.
- Trial name
- NCT05304949
- Testing
- Lucentis
- Where
- 6 sites in South Korea
- Volunteers
- 69 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Renal Cell Carcinoma
Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea
The objective of this study is to monitor the usage of INLYTA® in real practice, including the adverse events associated with INLYTA®.
- Trial name
- NCT02156895
- Testing
- Axitinib
- Where
- South Korea
- Volunteers
- 111 people
- Sponsor
- Pfizer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India
This study will follow patients with metastatic hormone-sensitive prostate cancer in India who receive darolutamide plus androgen deprivation therapy as part of routine medical care.
- Trial name
- PACE mHSPC (NCT07806591)
- Testing
- Darolutamide plus androgen deprivation therapy
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Bayer
Digital Nerve Injury
SECURE Post-Market Study
The purpose of this post-market study is to generate post-market, real- world evidence on the safety and performance of COAPTIUM® CONNECT with TISSIUM® LIGHT for the atraumatic sutureless repair of acute digital (sensory)…
- Trial name
- SECURE PMS (NCT07756489)
- Testing
- COAPTIUM® CONNECT
- Volunteers
- 65 people
- Sponsor
- Tissium
Hypertension, Pulmonary
Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH )
This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment.
- Trial name
- JPMS-CTEPH (NCT02117791)
- Testing
- Riociguat (ADEMPAS, BAY63-2521)
- Where
- Japan
- Volunteers
- 1,298 people
- Sponsor
- Bayer
Bronchial Asthma
Fasenra Pediatric Japan Post-Marketing Study(PMS)
The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra). 1.
- Trial name
- NCT06427876
- Where
- 9 sites in Japan
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Total Knee Arthroplasty
GMK Sphere TiNb Total Knee Arthroplasty PMS Study
Total knee arthroplasty (TKA) is one of the success stories of modern surgery, providing high patient satisfaction outcomes. Total knee prostheses are generally composed by a femoral component articulating on a polyethylene…
- Trial name
- NCT04801654
- Testing
- blood sample
- Where
- Italy
- Volunteers
- 155 people
- Sponsor
- Medacta International SA
Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections
Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events.
- Conditions
- Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections, Community-Acquired Bacterial Pneumonia
- Trial name
- NCT01072539
- Testing
- tigecycline
- Where
- 36 sites in South Korea
- Volunteers
- 3,172 people
- Sponsor
- Pfizer
Aortic Stenosis Treated With TAVI
The ShortCut Post-Market Study
This is a post-market, prospective, multicenter, single-arm post market study sponsored by Pi-Cardia Ltd. The ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve…
- Trial name
- ShortCut PMS (NCT07631988)
- Testing
- Transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR
- Volunteers
- 150 people
- Sponsor
- Pi-cardia
PMS, Hot Flashes
A Study to Evaluate the Effects of RCN3028 on Moderate to Severe Vasomotor Symptoms in Women
Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal women. Clinical evidence indicates potent antagonists of 5-HT2A are more likely to cause hypothermia.
- Trial name
- RDC (NCT02100540)
- Testing
- II RDC 0.3mg capsule, III RDC 0.6mg capsule
- Where
- Taiwan
- Volunteers
- 58 people
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
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
Osteoarthritis, Post-traumatic Arthritis
A Randomised Single Centre Study to Compare the Long-term Performance of Acryloc™ and Palacos® R Bone Cements in Primary Total Hip Replacement
The purpose of this study is to monitor the stability of a total hip replacement within the thigh bone when used in artificial hip joints implanted with two different bone cements, Acryloc™ and Palacos® R, in the treatment of…
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis
- Trial name
- NCT00208403
- Testing
- Acryloc™ GHV, Palacos R
- Where
- Norway
- Volunteers
- 36 people
- Sponsor
- DePuy International
Safety
Samsca PMS in ADPKD Patients
This is a Post-Marketing Surveillance study(PMS) of Samsca® tablets in actual use in cases to slow the progression of cyst development and renal insufficiency in accordance with Korean regulations on Risk Management Plan(RMP) and…
- Trial name
- NCT03406286
- Testing
- Tolvaptan
- Where
- South Korea
- Volunteers
- 2,067 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.