Clinical trials: Surveillance
Intracranial Atherosclerosis
Post Market Surveillance Study of the Wingspan Stent System
The primary objective of this study is to evaluate the rate of stroke and/or death in patients treated with the Wingspan Stent System, according to the Indications for Use, within 72 hours post procedure.
- Trial name
- WEAVE (NCT02034058)
- Testing
- Wingspan Stent System
- Where
- 26 sites in United States
- Volunteers
- 152 people
- Sponsor
- Stryker Neurovascular
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
Chronic Heart Failure
A Study to Learn More About How Safe Finerenone is and How Well it Works in Adults With Chronic Heart Failure in South Korea
This is an observational study in which data from people with chronic heart failure (HF) with left ventricular ejection fraction (LVEF) ≥ 40%. who will be receiving finerenone are studied.
- Trial name
- NCT07379840
- Testing
- finerenone (BAY94-8862)
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Bayer
Schizophrenia, Major Depressive Disorder
"Brexpiprazole (Rexulti™) Safety and Efficacy Among Filipino Patients (RAISE) - A Post Marketing Surveillance Program"
The objective of this post marketing surveillance is to further gather local data on the safety and efficacy of Brexpiprazole (RexultiTM) Film-coated Tablet in the treatment of schizophrenia and adjunctive therapy of Major…
- Trial name
- RAISE (NCT04641780)
- Testing
- Brexpiprazole
- Where
- Philippines
- Volunteers
- 300 people
- Sponsor
- Otsuka Pharmaceutical, Inc., Philippines
Heart Failure
The Product Surveillance Registry REVERSE Post Approval Study
The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.
- Trial name
- PSR-REVERSE (NCT01660035)
- Where
- 123 sites in United States, Belgium and 8 more
- Volunteers
- 155 people
- Sponsor
- Medtronic
Inoperable or Recurrent Breast Cancer
Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)
To investigate of the clinical safety and effectiveness of eribulin mesylate in patients with inoperable or recurrent breast cancer
- Trial name
- NCT01463891
- Testing
- Eribulin Mesylate
- Where
- 223 sites in Japan
- Volunteers
- 963 people
- Sponsor
- Eisai Co., Ltd.
Pulmonary Disease, Chronic Obstructive
Postmarketing Surveillance Study of Atrovent® Inhalation Solution in Chronic Obstructive Pulmonary Disease
To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice
- Trial name
- NCT02238197
- Testing
- Atrovent® Inhalation Solution
- Volunteers
- 477 people
- Sponsor
- Boehringer Ingelheim
Neuropathic Pain
Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)
The objective of this investigation is to evaluate the safety and efficacy of long term use with Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will…
- Trial name
- RAINBOW-L (NCT01279850)
- Testing
- Pregabalin (Lyrica) capsule
- Volunteers
- 891 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
Carotid Artery Disease
A Carotid Stenting Boston Scientific Surveillance Program
CABANA is a multicenter U.S. surveillance registry that will be conducted to compile early clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice and to assess the…
- Trial name
- CABANA (NCT00741091)
- Testing
- Carotid WALLSTENT Monorail Endoprosthesis, FilterWire EZ™ System™
- Where
- 112 sites in United States
- Volunteers
- 1,097 people
- Sponsor
- Boston Scientific Corporation
Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)
Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing…
- Trial name
- NCT05665374
- Where
- 15 sites in Japan
- Volunteers
- 67 people
- Sponsor
- AstraZeneca
Hepatocellular Carcinoma
Post-marketing Surveillance of DC Bead in Patients With Hepatocellular Carcinoma
This surveillance's objectives are: 1. Unknown adverse reactions 2. Incidences of adverse drug reaction 3. Factors considered to have effect to safety and effectiveness
- Trial name
- NCT02269995
- Testing
- E7040
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- Eisai Co., Ltd.
Hepatitis A
Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) "Basic standard for reexamination of new drug".
- Trial name
- NCT01838070
- Where
- South Korea
- Volunteers
- 614 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Spondylolisthesis, Neurologic Deficits
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
The purpose of the Post-Market Surveillance study is to evaluate safety.
- Conditions
- Spondylolisthesis, Neurologic Deficits, Kyphosis, Pseudarthrosis
- Trial name
- DSS (NCT01461005)
- Testing
- Dynamic Stabilization System (DSS)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Paradigm Spine
Osteoarthritis, Hip, Rheumatoid Arthritis
Avenir Müller Hip Stem Post Market Surveillance Study
This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2.
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis, Fracture of Hip, Dislocated Hip
- Trial name
- NCT04079127
- Testing
- Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.
- Volunteers
- 150 people
- Sponsor
- Zimmer Biomet
Renal Cell Carcinoma
A Post Marketing Surveillance As Required By Philippine Food And Drug Administration
This is a post marketing surveillance which determines the safety profile of the product to Filipinos. This is a FDA requirement for registration.
- Trial name
- NCT01781442
- Testing
- Temsirolimus
- Sponsor
- Pfizer
Contraception
Yasmin Post Marketing Surveillance
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.
- Trial name
- NCT00923572
- Testing
- EE30/DRSP (Yasmin, BAY86-5131)
- Where
- South Korea
- Volunteers
- 777 people
- Sponsor
- Bayer
Endometriosis
Regulatory Post Marketing Surveillance Study in Korea
The objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a subset of patients - at optional long-term…
- Trial name
- NCT01788722
- Testing
- Dienogest (Visanne, BAY86-5258)
- Where
- South Korea
- Volunteers
- 3,223 people
- Sponsor
- Bayer
Breast Neoplasm
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS).
- Trial name
- NCT03445637
- Where
- South Korea
- Volunteers
- 552 people
- Sponsor
- Pfizer
Psoriasis
Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis
This is an observational safety study tracking psoriasis patients on etanercept (Enbrel) for 5 years.
- Trial name
- NCT00322439
- Testing
- Etanercept
- Volunteers
- 2,511 people
- Sponsor
- Amgen
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