Clinical trials: Safety of Intervention
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria
This study aimed to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to < 18 years of…
- Trial name
- KALUMI (NCT04546633)
- Testing
- KAF156, LUM-SDF, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 3 more
- Volunteers
- 295 people
- Sponsor
- Novartis Pharmaceuticals
Diagnostic, Procedures and Surgeries on or Through Accessible Mucous Membranes
Topical Application of Cocaine HCl 4% and 10% on Safety and Efficacy in Local (Topical) Anesthesia
This study aims to evaluate topical application of Cocaine HCl 4% and 10% on safety and efficacy in local (topical) anesthesia for diagnostic procedures and surgeries on or through accessible mucous membranes of the nasal…
- Conditions
- Diagnostic, Procedures and Surgeries on or Through Accessible Mucous Membranes, of the Nasal Cavities
- Trial name
- NCT01746940
- Testing
- Cocaine HCl 4% Topical Solution, Cocaine HCl 10% Topical Solution
- Where
- 2 sites in United States
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Lannett Company, Inc.
Bloodloss, Surgical Procedures, Operative
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.
- Trial name
- CONSERV-1 (NCT00816023)
- Testing
- ecallantide
- Where
- 29 sites in United States, Canada
- Volunteers
- 276 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Atrial Fibrillation
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
- Trial name
- STELLAR (NCT03683030)
- Testing
- Multi-Electrode RF Balloon Catheter
- Where
- 41 sites in United States, China and 1 more
- Volunteers
- 397 people
- Sponsor
- Biosense Webster, Inc.
Chronic Thromboembolic Pulmonary Hypertension
A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment
Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other…
- Trial name
- SELECT (NCT03689244)
- Testing
- Selexipag
- Where
- 162 sites in United States, Argentina and 29 more
- Volunteers
- 128 people
- Sponsor
- Actelion
Osteoporosis
Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis
Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)
- Trial name
- DIRECT (NCT00680953)
- Testing
- Denosumab, Alendronate sodium hydrate
- Where
- 4 sites in Japan
- Volunteers
- 1,262 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Nasal Congestion
The Safety and Efficacy of a SinuSonic Intervention
This study aims to test the safety and effectiveness of the SinuSonic device on adults with moderate to severe nasal congestion.
- Trial name
- NCT03906968
- Testing
- SinuSonic Device
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Medical University of South Carolina
Discoid Lupus Erythematosus
Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients
The purpose of this study is to determine the clinical and immunological effects of the phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous lupus erythematosus.
- Trial name
- NCT00708916
- Testing
- CC-10004
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- NYU Langone Health
Major Depressive Disorder
Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder
To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in patients with Major Depressive Disorder (MDD)
- Trial name
- NCT01944969
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- H. Lundbeck A/S
Serious Fungal Infections
Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea
This is a non-interventional study of voriconazole tablet in Korea which is mandated by the Korean government agency.
- Trial name
- NCT01073631
- Testing
- voriconazole tablet
- Volunteers
- 543 people
- Sponsor
- Pfizer
Wilson's Disease
Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily).
A randomised, open-label study evaluating the pharmacokinetics, safety, and tolerability of a new once daily dose of 900mg of TETA 4HCL by comparing it against the current marketed Cuprior® formulation (450mg trientine base…
- Trial name
- NCT06128954
- Testing
- 900mg TETA 4HCl Once Daily Formulation, 900mg TETA 4HCl Cuprior®
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Orphalan
Advanced/Metastatic Gastroesophageal Adenocarcinoma
Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)
The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic…
- Trial name
- NCT04662710
- Testing
- Pembrolizumab, Lenvatinib, Oxaliplatin
- Where
- 177 sites in United States, Argentina and 22 more
- Volunteers
- 895 people
- Sponsor
- Merck Sharp & Dohme LLC
Arthroscopy, Bunionectomy
A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures
The purpose of this study is to determine the safety, tolerability, and efficacy of AQUAVAN® Injection when used for mild-to-moderate sedation in patients undergoing minor surgical procedures.
- Conditions
- Arthroscopy, Bunionectomy, Osteotomy, Carpal Tunnel
- Trial name
- NCT00209560
- Testing
- fospropofol disodium
- Volunteers
- 168 people
- Sponsor
- Eisai Inc.
COVID-19
Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).
The primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.
- Trial name
- NCT05011513
- Testing
- PF-07321332, Ritonavir
- Where
- 225 sites in United States, Argentina and 18 more
- Volunteers
- 1,440 people
- Sponsor
- Pfizer
Von Willebrand Disease
Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery
The purpose of the study is to assess the efficacy and safety of recombinant von Willebrand factor (rVWF) with or without ADVATE in major and minor elective surgical procedures in adult patients with hereditary severe von…
- Trial name
- NCT02283268
- Testing
- Recombinant von Willebrand Factor (rVWF)
- Where
- 34 sites in United States, Australia and 11 more
- Volunteers
- 24 people
- Sponsor
- Baxalta now part of Shire
Peripheral Artery Disease
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the…
- Trial name
- VOYAGER PAD (NCT02504216)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 532 sites in United States, Argentina and 32 more
- Volunteers
- 6,564 people
- Sponsor
- Bayer
Poliomyelitis
Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia
The purpose of this study is to assess reactogenicity and safety of simultaneous administration of GSK Biologicals' inactivated poliomyelitis vaccine Poliorix and GSK Biologicals' DTPa-vaccine Infanrix vaccines in healthy…
- Trial name
- NCT01094171
- Testing
- Poliorix TM, Infanrix TM
- Where
- 2 sites in Russia
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Advanced Breast Cancer
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or…
- Trial name
- ALPINIST (NCT05631795)
- Testing
- Alpelisib, Fulvestrant
- Where
- 12 sites in India
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Factor VIII Deficiency
A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A
Primary Objective: To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm. Secondary Objectives: To evaluate the efficacy of BIVV001 as a prophylaxis treatment.
- Trial name
- XTEND-1 (NCT04161495)
- Testing
- efanesoctocog alfa (BIVV001)
- Where
- 47 sites in United States, Argentina and 17 more
- Volunteers
- 159 people
- Sponsor
- Bioverativ, a Sanofi company
End Stage Renal Disease, Thrombosis
Safety and Efficacy Study of AB002 (E-WE Thrombin) in End Stage Renal Disease Patients on Chronic Hemodialysis
This study evaluates the safety and efficacy of AB002 (E-WE thrombin) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts.
- Trial name
- NCT03963895
- Testing
- AB002 Dose 1, AB002 Dose 2
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Aronora, Inc.