Clinical trials: Safety Plan
Neuralgia
Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan)
The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored…
- Trial name
- RAINBOW (NCT01256593)
- Testing
- Pregabalin (Lyrica) capsule
- Volunteers
- 3,827 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Platelet Aggregation Inhibitors, NSTEACS
Efficacy and Safety in Patients With Acute Coronary Syndrome Without ST-Segment Elevation
To evaluate the efficasy and safety of SR25990C(loading dose:300mg, maintenance dose:75mg/day) in comparison with the standard Japanese treatment(ticlopidine) in patients with acute coronary syndrome without ST-segment elevation…
- Trial name
- NCT00325390
- Testing
- clopidogrel (SR25990C)
- Where
- Japan
- Volunteers
- 800 people
- Sponsor
- Sanofi
Hematologic Malignancies
Safety Study of Gene Modified Donor T-Cells in Adults With Advanced Hematologic Malignancies
This is an open-label, non-randomized study to evaluate the safety of two planned infusions of BPX-501 T cells after partially mismatched, related (haploidentical) HSCT in adults with hematologic malignancies.
- Trial name
- NCT02487459
- Testing
- BPX-501, AP1903
- Where
- United States
- Sponsor
- Bellicum Pharmaceuticals
Healthy Male Adults Participants, Vasectomy
Plan A Novel Delivery Device Study
This study will evaluate the safety and usability of the Delivery Lumen Access Device (DLAD) in accessing the vas deferens in up to 30 healthy males. This is a prospective, non-randomized, open label interventional study.
- Trial name
- NCT06891729
- Testing
- Delivery Lumen Access Device, DLAD
- Where
- 2 sites in Australia, Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Next Life Sciences
Chronic Myeloid Leukemia, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Iclusig PMS in CML or Ph+ALL Patients
This is a Post-Marketing Surveillance (PMS) of Iclusig® Tablets in accordance with Korean regulations on Risk Management Plan (RMP).
- Trial name
- NCT03709017
- Testing
- Ponatinib
- Where
- South Korea
- Volunteers
- 50 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Suicidal Ideation
Virtual Training Role-Plays to Improve Patient Suicide Outcomes in Primary Care Settings
SIMmersion, in collaboration with the Institute for Family Health (IFH) and the Educational Development Center (EDC) propose to develop a web-based training product, Suicide Prevention Role-plays for Interactive Training…
- Trial name
- NCT03207217
- Testing
- Web-based training Product
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- SIMmersion, LLC
Non-tuberculous Mycobacterial Diseases, Tuberculosis
Safety And Efficacy Of Rifabutin In HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Conditions
- Non-tuberculous Mycobacterial Diseases, Tuberculosis, Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
- Trial name
- NCT00810446
- Testing
- rifabutin
- Volunteers
- 72 people
- Sponsor
- Pfizer
Adhesion
Safety and Tolerability of Seroguard Use
The performed study of safety and tolerability of Seroguard, solution (JSC Pharmasyntez, Russia) in patients, undergoing planned laparoscopic cholecystectomy, demonstrated that patients from the both groups had the similar safety…
- Trial name
- NCT03640559
- Testing
- Seroguard
- Volunteers
- 50 people
- Sponsor
- Pharmasyntez
Helminthiasis, Amoebiasis
Study to Evaluate Efficacy and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population
The purpose of this study is to assess the efficacy and safety of the combination of mebendazole plus quinfamide for the treatment of intestinal helminthiasis and amoebiasis in Mexican population.
- Trial name
- NCT02385058
- Testing
- Mebendazole, Quinfamide
- Where
- Mexico
- Volunteers
- 100 people
- Sponsor
- Janssen-Cilag Ltd.
Coronary Artery Disease, Percutaneous Coronary Intervention
The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel
This is a multi-center, randomized, double-blind, triple-dummy, parallel-controled, dose-exploration phase II trial. Patients with coronary atherosclerotic heart disease and planned percutaneous coronary intervention （PCI） will…
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
- Trial name
- NCT03599284
- Testing
- Vicagrel 5mg, Vicagrel 6mg, Vicagrel 7.5mg
- Where
- 27 sites in China
- Volunteers
- 279 people
- Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
Critical Limb Ischemia, Peripheral Vascular Disease
Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to…
- Conditions
- Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers, Rest Leg Pain
- Trial name
- NCT00060996
- Testing
- Remodulin® (treprostinil sodium) Injection
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- United Therapeutics
High-risk Localized Prostate Cancer
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make…
- Trial name
- CHINANEO (NCT07450599)
- Testing
- Darolutamide, ADT
- Where
- 23 sites in China
- Volunteers
- 250 people
- Sponsor
- Bayer
Alzheimer's Disease
A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
The purpose of the study is for investigation and collection of Aricept safety information with a dose increase on Alzheimer's disease patients.
- Trial name
- AID (NCT02158910)
- Testing
- Aricept
- Where
- 13 sites in South Korea
- Volunteers
- 2,231 people
- Sponsor
- Eisai Korea Inc.
Allergic Rhinitis
Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children.
The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years.
- Trial name
- SIERRA (NCT06272409)
- Testing
- DEP114, Desloratadine 0.5 MG/ML
- Volunteers
- 318 people
- Sponsor
- EMS
Chronic Hepatitis B
Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.
- Trial name
- NCT01026610
- Testing
- LB80380 90 mg, LB80380 150 mg, entecavir 0.5 mg
- Where
- 10 sites in China, South Korea
- Volunteers
- 115 people
- Sponsor
- LG Life Sciences
Non-small Cell Lung Cancer
Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT01597258
- Testing
- Crizotinib (Xalkori)
- Volunteers
- 2,029 people
- Sponsor
- Pfizer
Pneumococcal Vaccine, Streptococcus Pneumoniae
Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months…
- Trial name
- NCT01521897
- Testing
- 7-valent vaccine injection
- Where
- Japan
- Volunteers
- 1,143 people
- Sponsor
- Pfizer
Open-Angle Glaucoma, Ocular Hypertension
Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%
The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual active components in subjects with open-angle…
- Trial name
- NCT01297920
- Testing
- Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, Brinzolamide ophthalmic suspension, 1%, Brimonidine tartrate ophthalmic solution, 0.2%
- Volunteers
- 1,062 people
- Sponsor
- Alcon Research
Cardiac Surgery, Ischemia Limb
Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach
This is a first-in-human, prospective, single-arm, phase I clinical study evaluating the safety of the iPerf femoral arterial cannula in patients undergoing planned cardiac surgery requiring extracorporeal circulation (ECC) via a…
- Trial name
- FIH IPERF-01 (NCT07163234)
- Testing
- Cardiac surgery
- Where
- 2 sites in France
- Volunteers
- 15 people
- Sponsor
- IPERF SAS
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