Clinical trials: Surveillance
Symptomatic Aortic Stenosis
The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS)
The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) has been demonstrated to be safe and effective for high through extreme risk patients with symptomatic severe native aortic stenosis or a stenosed…
- Trial name
- CoreValveIndia (NCT02759237)
- Testing
- CoreValve System Family
- Where
- India
- Volunteers
- 3 people
- Sponsor
- Medtronic Cardiovascular
Hemophilia A
Drug Use Investigation of Kovaltry in Hemophilia A Patients
The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.
- Trial name
- 18706 (NCT02941783)
- Testing
- Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
- Volunteers
- 230 people
- Sponsor
- Bayer
Rheumatoid Arthritis, Osteoarthritis
An Electronic Data Capture Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement
The purpose of this study is to monitor the performance of the DePuy PROXIMA™ hip in the treatment of patients with hip joint disease requiring a total hip replacement.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis
- Trial name
- NCT01134445
- Testing
- DePuy Proxima™ Hip
- Where
- 4 sites in France, Portugal and 2 more
- Volunteers
- 42 people
- Sponsor
- DePuy International
Asthma
Specific Use-result Surveillance of Spiriva Respimat in Asthmatics
The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva® Respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials.
- Trial name
- NCT02489981
- Testing
- Spiriva
- Where
- Brazil
- Volunteers
- 359 people
- Sponsor
- Boehringer Ingelheim
Diabetes, Diabetes Mellitus, Type 2
Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 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 type 2 diabetes mellitus in routine clinical practice in India.
- Trial name
- NCT03070704
- Testing
- insulin degludec/liraglutide
- Sponsor
- Novo Nordisk A/S
Multiple Sclerosis, Relapsing-remitting
A Study for Tecfidera (Dimethyl Fumarate) Capsules in Korean Participants With Relapsing-Remitting Multiple Sclerosis
The primary purpose of this study is to evaluate the overall safety and efficacy of Tecfidera (Dimethyl Fumarate) as an oral treatment for Korean participants with relapsing-remitting multiple sclerosis (MS) under routine…
- Trial name
- NCT05366036
- Testing
- No Intervention
- Where
- 20 sites in South Korea
- Volunteers
- 172 people
- Sponsor
- Eisai Korea Inc.
Leukemia, Myelomonocytic, Chronic, Leukemia-Lymphoma
Korean Post-marketing Surveillance for Sprycel®
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 Sprycel® so that the regulatory…
- Trial name
- NCT01464047
- Where
- South Korea
- Volunteers
- 670 people
- Sponsor
- Bristol-Myers Squibb
Hypertension, Dyslipidemias
Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy
Post-marketing surveillance of Telostop TAB (Telmisartan/Rosuvastatin)
- Trial name
- NCT03742544
- Volunteers
- 600 people
- Sponsor
- IlDong Pharmaceutical Co Ltd
Acute Kidney Injury, Fluid Overload
Prospective, Multi-center, Single-arm, Observational Study. US FDA 522 Pediatric Post Market Surveillance Study.
The post market surveillance study will employ a prospective, multi-center, single-arm, observational design to capture data on children who undergo CRRT using the Carpediem™ system.
- Trial name
- NCT04608149
- Testing
- Carpediem System
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- Mozarc Medical US LLC
Vascular Stent-Graft Stenosis
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study
This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the…
- Trial name
- NCT04429243
- Testing
- GORE® VIABAHN® Stent Graft
- Where
- 17 sites in Japan
- Volunteers
- 124 people
- Sponsor
- W.L.Gore & Associates
Hemophilia A
Kogenate FS Regulatory Post-Marketing Surveillance
To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications. The observation period for each patient is up to 6 months.
- Trial name
- KG0910KR (NCT01386268)
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- South Korea
- Volunteers
- 64 people
- Sponsor
- Bayer
Human Papillomavirus Infection Leading to Cervical Cancer
A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.
The purpose of this study was to assess the safety and reactogenicity of GSK Biologicals' Cervarix vaccine in healthy female Filipino subjects from the age of 10 years onwards, as per the Bureau of Food and Drugs Directive of…
- Trial name
- NCT00730847
- Testing
- Cervarix
- Where
- 2 sites in Philippines
- Volunteers
- 743 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Immunisation Against Streptococcus Pneumoniae
Post-marketing Safety Study of GlaxoSmithKline (GSK) Biologicals' Synflorix™ Vaccine, in Healthy Infants and Children in Sri Lanka
This PMS study aims to collect safety and reactogenicity data of Synflorix™ in healthy infants and children of the local population as per the licensing requirement of the Sri Lankan regulatory authority.
- Trial name
- NCT01803425
- Testing
- Synflorix™ data collection
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Asthma, EGPA(Eosinophilic Granulomatosis With Polyangiitis)
FASENRA Regulatory Postmarketing Surveillance in Korea
As part of a post approval commitment, the MFDS has requested a study to characterize safety in patients who are treated with FASENRA for severe eosinophilic asthma and/or eosinophilic granulomatosis with polyangiitis (EGPA) by…
- Trial name
- FASENRA rPMS (NCT05091333)
- Where
- 5 sites in South Korea
- Volunteers
- 51 people
- Sponsor
- AstraZeneca
Infections, Papillomavirus
Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females
This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs…
- Trial name
- NCT01101542
- Testing
- Cervarix., Data collection
- Where
- 2 sites in South Korea
- Volunteers
- 3,091 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hypertension
Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months)
The purpose of this study is to evaluate the safety and efficacy of long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD) Combination Tablets LD\&HD in hypertensive patients in the routine…
- Trial name
- NCT02016183
- Testing
- Candesartan cilexetil / hydrochlorothiazide
- Where
- Japan
- Volunteers
- 3,222 people
- Sponsor
- Takeda
Hypertension
Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use
The survey is conducted to collect safety and effectiveness information in Hypertensive patients treated with Micombi Tablets on the long term use in daily clinical settings in Japan.
- Trial name
- NCT01050062
- Testing
- Telmisartan 80mg, Telmisartan 40mg, Hydrochlorothiazide 12.5mg
- Where
- 314 sites in Japan
- Volunteers
- 1,452 people
- Sponsor
- Boehringer Ingelheim
Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis
Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients
The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
- Trial name
- NCT01901107
- Testing
- Kiklin capsules
- Where
- 8 sites in Japan
- Volunteers
- 1,078 people
- Sponsor
- Astellas Pharma Inc
A History of Gastric or Duodenal Ulcers
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"
The purpose of this study is to investigate the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine clinical setting in patients receiving non-steroidal…
- Trial name
- NCT03214198
- Testing
- Vonoprazan
- Where
- Japan
- Volunteers
- 1,304 people
- Sponsor
- Takeda
Generalized Pustular Psoriasis
PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms
Non-interventional cohort study in patients with newly initiated Spesolimab to evaluate the incidence of adverse drug reactions and to understand generalized pustular psoriasis (GPP) disease activities in the real world setting.
- Trial name
- NCT05670821
- Testing
- Spesolimab
- Where
- Japan
- Volunteers
- 52 people
- Sponsor
- Boehringer Ingelheim
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