Clinical trials: Surveillance
Coronary Artery Disease
CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)
The purpose of this PMS registry, named e-CYPHER Stent Registry, is to collect post marketing surveillance data on the CYPHERTM Sirolimus-eluting Coronary Stent following marketing approval, when used in normal clinical practice…
- Trial name
- NCT00245401
- Testing
- CYPHERTM Sirolimus-Eluting Coronary Stent
- Volunteers
- 2,070 people
- Sponsor
- Cordis US Corp.
COVID-19
A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People
The purpose of this study is to characterize descriptively the BNT162b2 vaccination safety experience among the Indonesian people.
- Trial name
- NCT05621239
- Testing
- BNT162b2
- Where
- Indonesia
- Volunteers
- 260 people
- Sponsor
- Pfizer
Premenopausal Breast Cancer
Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
- Trial name
- NCT03209518
- Testing
- Leuprorelin acetate
- Where
- Japan
- Volunteers
- 312 people
- Sponsor
- Takeda
Ischemic Stroke
Trevo® Retriever Registry Post Market Surveillance
The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic…
- Trial name
- NCT02040259
- Where
- 80 sites in United States, Canada and 10 more
- Volunteers
- 2,008 people
- Sponsor
- Stryker Neurovascular
Renal Cell Carcinoma
Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing: 1. Confirmation of efficacy and safety for medical practice use. 2.
- Trial name
- NCT01210482
- Testing
- Temsirolimus
- Where
- Japan
- Volunteers
- 1,050 people
- Sponsor
- Pfizer
Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial
Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)
The purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children.
- Conditions
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria
- Trial name
- NCT00761527
- Testing
- Desloratadine Syrup
- Volunteers
- 2,980 people
- Sponsor
- Organon and Co
Type 2 Diabetes Melitus
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"
The purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to…
- Trial name
- NCT01945242
- Testing
- Alogliptin
- Volunteers
- 1,374 people
- Sponsor
- Takeda
Diagnostic Imaging
Magnevist 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 Magnevist at a dose of more than 0.2 ml/kg for MR angiography of peripheral…
- Trial name
- NCT01376739
- Testing
- Gadopentetate dimeglumine (Magnevist, BAY86-4882)
- Where
- Japan
- Volunteers
- 2,051 people
- Sponsor
- Bayer
Hemophilia B
Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
Primary: To characterize the safety of RIXUBIS when used under normal clinical care in South Korea. Secondary: To describe hemostatic effectiveness in subjects receiving RIXUBIS under normal clinical care in South Korea.
- Trial name
- NCT02922231
- Testing
- RIXUBIS
- Where
- 5 sites in South Korea
- Volunteers
- 57 people
- Sponsor
- Baxalta now part of Shire
Rheumatoid Arthritis
Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan
The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives…
- Trial name
- NCT00503139
- Testing
- Enbrel (etanercept)
- Where
- Japan
- Volunteers
- 684 people
- Sponsor
- Pfizer
Pertussis
Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine
To further characterize the vaccine safety profile and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.
- Trial name
- NCT00258882
- Testing
- Tetanus Toxoid, acellular pertussis, diphtheria toxoid
- Where
- 3 sites in United States
- Volunteers
- 327,293 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diabetes Mellitus, Type 2
Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics of patients with type 2 diabetes mellitus…
- Trial name
- NCT01650259
- Testing
- OAD, Trazenta
- Where
- Japan
- Volunteers
- 4,876 people
- Sponsor
- Boehringer Ingelheim
Microcephaly, Congenital Infection
Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia
This study will explore whether ZIKV is currently responsible for neurological complications, and particularly microcephaly, in Aedes-infested regions of Sub-Saharan Africa (SSA) and Asia.
- Trial name
- NCT03922594
- Testing
- Differential diagnosis for infectious causes of microcephaly
- Where
- 8 sites in Cameroon, China and 3 more
- Volunteers
- 150 people
- Sponsor
- Institut Pasteur
Meningococcal Infection
Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
Primary Objective: To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).
- Trial name
- NCT04843111
- Testing
- Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Lupus Erythematosus, Systemic
SAPHNELO Systemic Lupus Erythematosus Japan Post-Marketing Surveillance (PMS)
To collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus in the real-world post-marketing setting.
- Trial name
- NCT05141201
- Where
- 47 sites in Japan
- Volunteers
- 1,620 people
- Sponsor
- AstraZeneca
Hypertension
Post Marketing Surveillance (PMS) Study to Assess Safety and Efficacy of Micardis in Patients With Essential Hypertension
The objective of this PMS study was to monitor and assess the safety of Micardis tablets in patients with hypertension over a period of 6 years
- Trial name
- NCT02245464
- Testing
- Telmisartan
- Volunteers
- 13,066 people
- Sponsor
- Boehringer Ingelheim
Intracranial Aneurysm
COMPLEX Post Market Surveillance Electronic Registry
To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.
- Trial name
- COMPLEX (NCT00663299)
- Testing
- Endovascular Embolization Device
- Where
- Japan
- Volunteers
- 299 people
- Sponsor
- Codman & Shurtleff
Chronic Pain, Spasticity, Muscle
Medtronic PSR TDD PMCF
The purpose of this study is to provide continuing evaluation and reporting of safety and performance of the SynchroMed II Infusion System within its intended use. Data will support post-market surveillance obligations.
- Trial name
- NCT04714385
- Where
- 15 sites in Belgium, Czechia and 6 more
- Volunteers
- 209 people
- Sponsor
- Medtronic
Meningitis, Meningococcal Infection
Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children
This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose.
- Trial name
- NCT01689155
- Testing
- Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hemophilia B
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
To provide safety and effectiveness information of BeneFIX during the post-marketing period as required by Korea FDA regulations, to identify any potential drug related treatment factors in Korean population including: 1) Unknown…
- Trial name
- NCT00484185
- Testing
- BeneFIX (coagulation factor IX (recombinant))
- Where
- South Korea
- Volunteers
- 183 people
- Sponsor
- Pfizer