Clinical trials: Safety Plan
Infantile Neuroaxonal Dystrophy
A Study to Assess Efficacy and Safety of RT001 in Subjects With Infantile Neuroaxonal Dystrophy
The purpose of this study is to evaluate the efficacy and safety of RT001 in patients with Infantile Neuroaxonal Dystrophy (INAD).
- Trial name
- NCT03570931
- Testing
- RT001
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Biojiva LLC
HIV-1 Infection
Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this…
- Trial name
- NCT00823966
- Testing
- Rescriptor
- Volunteers
- 3 people
- Sponsor
- Pfizer
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
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
Epilepsies, Partial
Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
This investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study: The frequency of treatment related adverse events.
- Trial name
- NCT01441401
- Testing
- gabapentin
- Volunteers
- 82 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Tuberculosis, Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
Safety And Efficacy Of Rifabutin In Patients For Non-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…
- Trial name
- NCT00810407
- Testing
- rifabutin
- Volunteers
- 628 people
- Sponsor
- Pfizer
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.
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.
CCR5-tropic HIV-1 Infection
Safety And Efficacy Of Maraviroc In Patients For HIV Patients (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
- NCT00864474
- Testing
- CELSENTRI® Tablets
- Volunteers
- 68 people
- Sponsor
- ViiV Healthcare
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.
Glaucoma, Ocular Hypertension
Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension
The objective of this Investigation is to evaluate the safety and efficacy of long-term treatment with Xalacom in medical practice.
- Trial name
- NCT01191008
- Testing
- Latanoprost-timolol maleate fixed combination ophthalmic solution
- Volunteers
- 661 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Suicide, Mental Health Disorder
A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents
Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be…
- Conditions
- Suicide, Mental Health Disorder, Anhedonia
- Trial name
- ViraSafeRCT (NCT07348666)
- Testing
- ViraSafe: Treatment pushes, BRITE
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Ksana Health
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.
Pneumococcal Infections
Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)
The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs)…
- Trial name
- PNEU-PLAN (NCT03885934)
- Testing
- V114, Prevnar 13®
- Where
- 26 sites in Finland, Malaysia and 3 more
- Volunteers
- 606 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Suicide, Mental Health Disorder
Optimizing a Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents
Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be…
- Conditions
- Suicide, Mental Health Disorder, Anhedonia
- Trial name
- NCT06665620
- Testing
- ViraBrite nudges
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Ksana Health
Chronic Myelogenous Leukemia
Safety And Efficacy Of Bosutinib
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 3.
- Trial name
- BLF (NCT02501330)
- Testing
- Bosutinib
- Volunteers
- 702 people
- Sponsor
- Pfizer
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
Hypertension
Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.
- Trial name
- ESSENCE (NCT00749775)
- Testing
- Selara
- Volunteers
- 3,338 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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