Clinical trials: Surveillance
Congenital Bleeding Disorder, Haemophilia A
Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia Database
This study is conducted in Europe. The purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rFVIIa.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- NCT00853086
- Testing
- activated recombinant human factor VII
- Where
- United Kingdom
- Volunteers
- 139 people
- Sponsor
- Novo Nordisk A/S
Brain Ischemia
Xarelto [SPAF] Post-marketing Surveillance in Japan
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.
- Trial name
- NCT01582737
- Testing
- Rivaroxaban(Xarelto, BAY59-7939)
- Where
- Japan
- Volunteers
- 11,310 people
- Sponsor
- Bayer
Conjunctivitis, Seasonal Allergic, Conjunctivitis, Giant Papillary
A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%
The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice
- Conditions
- Conjunctivitis, Seasonal Allergic, Conjunctivitis, Giant Papillary, Inflammation
- Trial name
- NCT01437982
- Testing
- Loteprednol Etabonate, Prednisolone Acetate 1% Oph Susp
- Where
- South Korea
- Volunteers
- 140 people
- Sponsor
- Bausch & Lomb Incorporated
Spinal Deformity
Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \& Trivium 3D Spinal Deformity Correction System.
- Trial name
- NCT01220505
- Testing
- Surgery
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 66 people
- Sponsor
- Zimmer Biomet
Neovascular Age-related Macular Degeneration
Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.
An open label, non-comparative, multicenter, non-interventional, post marketing surveillance study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the treatment of Filipino patients with…
- Trial name
- NCT00820742
- Testing
- Macugen
- Sponsor
- Pfizer
Esophageal Cancer, Lung Cancer
Case Analysis on Real Life Incidence of Photodynamic Therapy (PDT) Safety Outcomes
Three main adverse reactions, namely photosensitivity (reaction that is similar to sunburn), oesophageal stenosis (narrowing or closure of the food pipe), perforation of the treated area (a tear or puncture of the tissue), have…
- Conditions
- Esophageal Cancer, Lung Cancer, Barrett's Esophagus
- Trial name
- CALIPSO (NCT01203163)
- Sponsor
- Pinnacle Biologics Inc.
Abdominal Aortic Aneurysms (AAA)
The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
This is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1 year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and effectiveness of the Vascutek AnacondaTM…
- Trial name
- NCT01826344
- Where
- 71 sites in Austria, Belgium and 10 more
- Volunteers
- 628 people
- Sponsor
- Vascutek Ltd.
Coronary Artery Stenosis
Cordimax China Post Market Surveillance
Study purpose: This study is a prospective, randomized, controlled multicenter clinical research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they dealing with all kinds of complex lesions in the…
- Trial name
- NCT03185221
- Testing
- Cordimax, XIENCE V
- Where
- China
- Volunteers
- 3,660 people
- Sponsor
- Shandong Branden Med.Device Co.,Ltd
Kidney Disease, Chronic
JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD)
The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice.
- Trial name
- NCT06287073
- Testing
- JARDIANCE®
- Where
- 12 sites in South Korea
- Volunteers
- 299 people
- Sponsor
- Boehringer Ingelheim
Hypertension
Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter
The Study objective is to assess the performance of the Vessix V2 Renal Denervation System for the treatment of uncontrolled hypertension using an innovative percutaneous Radio Frequency (RF) balloon catheter renal denervation…
- Trial name
- REDUCE-HTN (NCT01541865)
- Testing
- Renal Denervation
- Where
- 26 sites in Australia, Austria and 6 more
- Volunteers
- 146 people
- Sponsor
- Boston Scientific Corporation
Hypertension
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
This is a single arm, multicenter, observational study to evaluate the safety and efficacy of Entresto Tablets during the first 52 weeks of treatment in Japanese patients with hypertension.
- Trial name
- ENLIGHT (NCT05976230)
- Testing
- Entresto
- Where
- 117 sites in Japan
- Volunteers
- 1,125 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma
Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma
This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study (regulatory postmarketing surveillance).
- Trial name
- NCT02717364
- Where
- 2 sites in Japan
- Volunteers
- 556 people
- Sponsor
- Bristol-Myers Squibb
Cervical Dystonia
Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition in Patients With Change From Botulinum Toxin Type A
Investigation of the clinical condition in patients with cervical dystonia by Toronto Western Spasmodic Torticollis Scale (TWSTRS)
- Trial name
- NCT02175719
- Where
- 2 sites in Japan
- Volunteers
- 150 people
- Sponsor
- Eisai Co., Ltd.
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System FOUNDATION Study
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Rapid Deployment Valves
- Trial name
- FOUNDATION (NCT02338154)
- Where
- 27 sites in Austria, Denmark and 7 more
- Volunteers
- 516 people
- Sponsor
- Edwards Lifesciences
Relapsing-Remitting Multiple Sclerosis
A Postmarketing Surveillance (PMS) Study to Evaluate the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis (MS) With Interferon Beta 1a (Rebif®)
This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study on the extent to which subject compliance is influenced by use of a variable titration regimen at the start of treatment of relapsing MS…
- Trial name
- TOURIMS (NCT01142492)
- Testing
- Interferon beta-1a
- Volunteers
- 403 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Intussusception (IS), Rotavirus Vaccines
Intussusception Surveillance After Rotarix Introduction in Mexico
GSK Biologicals' rotavirus vaccine, Rotarix™ has been recommended for universal use targeting infants through the Expanded Program on Immunization (EPI) in Mexico.
- Trial name
- NCT00595205
- Testing
- Hospital log review.
- Where
- Mexico
- Volunteers
- 786 people
- Sponsor
- GlaxoSmithKline
Cardiovascular Disease, de Novo Coronary Lesions
TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program
The TAXUS ARRIVE 2 study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical…
- Trial name
- ARRIVE 2 (NCT00569751)
- Testing
- TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System
- Where
- 53 sites in United States
- Volunteers
- 5,016 people
- Sponsor
- Boston Scientific Corporation
Diabetes Mellitus, Type 2
Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus
Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
- Trial name
- NCT02367131
- Testing
- JARDIANCE®
- Where
- Japan
- Volunteers
- 419 people
- Sponsor
- Boehringer Ingelheim
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
Intra-Abdominal Infections, Skin Disease, Infectious
Tygacil Drug Use Investigation
Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice
- Trial name
- TIGER (NCT01789905)
- Testing
- Tigecycline (Tygacil)
- Volunteers
- 116 people
- Sponsor
- Pfizer
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