Clinical trials: Standard Care Control
Venous Thromboembolism (VTE), Pulmonary Embolism
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE.
- Conditions
- Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)
- Trial name
- NCT02798471
- Testing
- Edoxaban, Standard of Care
- Where
- 140 sites in United States, Argentina and 32 more
- Volunteers
- 290 people
- Sponsor
- Daiichi Sankyo
Phenylketonurias
Open-label, Randomized, 2-way Crossover, Monocentric, Controlled Study to Evaluate the Effect on Daily PHE Fluctuation of PKU GOLIKE Versus SoC in Patients With PKU.
This is an open-label, randomized, 2-way crossover, monocentric controlled study in patients (≥ 16 years old) with phenylketonuria (PKU).
- Trial name
- NCT05827536
- Testing
- PKU GOLIKE, Standard of Care
- Where
- Italy
- Volunteers
- 21 people
- Sponsor
- APR Applied Pharma Research s.a.
Dravet Syndrome
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome
The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of ZX008 (fenfluramine hydrochloride) when added to adjunctive antiepileptic stiripentol treatment in children and young adults with Dravet…
- Trial name
- NCT02926898
- Testing
- ZX008 (Fenfluramine Hydrochloride)
- Where
- 28 sites in United States, Canada and 5 more
- Volunteers
- 87 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Asthma
Efficacy and Safety Study of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016)…
- Trial name
- NCT02555683
- Testing
- QAW039
- Where
- 234 sites in United States, Argentina and 25 more
- Volunteers
- 894 people
- Sponsor
- Novartis Pharmaceuticals
Venous Thromboembolism
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.
- Trial name
- EINSTEIN Jr (NCT02234843)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of Care
- Where
- 109 sites in United States, Argentina and 26 more
- Volunteers
- 500 people
- Sponsor
- Bayer
Asthma
Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
This study aimed to determine the efficacy and safety of QAW039 and QAW039 450 mg compared to placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the…
- Trial name
- NCT02563067
- Testing
- QAW039
- Where
- 163 sites in United States, Argentina and 17 more
- Volunteers
- 877 people
- Sponsor
- Novartis Pharmaceuticals
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
The purpose of this superiority study is to evaluate the efficacy and safety of exebacase in addition to standard of care antibiotics (SoCA) compared with SoCA alone for the treatment of patients with Staphylococcus aureus (S.
- Trial name
- DISRUPT (NCT04160468)
- Testing
- Exebacase
- Where
- 55 sites in United States
- Volunteers
- 259 people
- Sponsor
- ContraFect
Lung Diseases, Interstitial
A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)
The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).
- Trial name
- InPedILD® (NCT04093024)
- Testing
- Nintedanib
- Where
- 43 sites in United States, Argentina and 19 more
- Volunteers
- 39 people
- Sponsor
- Boehringer Ingelheim
Bronchiolitis
Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis
The purpose of this study is to determine whether nebulized 3% hypertonic saline is more effective than the current standard of care in the treatment of viral bronchiolitis in children.
- Trial name
- NCT02834819
- Testing
- 3% Nebulized Hypertonic Saline
- Volunteers
- 18 people
- Sponsor
- University of Colorado, Denver
Influenza A
A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications
The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
- Trial name
- NCT03381196
- Testing
- Pimodivir 600 mg, SOC Treatment
- Where
- 427 sites in United States, Argentina and 36 more
- Volunteers
- 553 people
- Sponsor
- Janssen Research & Development, LLC
Respiratory Tract Viral Infections, Human Metapneumovirus (hMPV) Infection
Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
A study to evaluate ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV), influenza, human metapneumovirus (hMPV)…
- Conditions
- Respiratory Tract Viral Infections, Human Metapneumovirus (hMPV) Infection, Parainfluenza (PIV) Infection, Respiratory Syncytial Viral (RSV) Infection
- Trial name
- NCT04933968
- Testing
- ALVR106
- Where
- 21 sites in United States
- Volunteers
- 17 people
- Sponsor
- AlloVir
Type 1 Diabetes
The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes
The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes…
- Trial name
- NCT04796779
- Testing
- Tandem t:slim X2 with Control-IQ Technology Pro, Standard Care (SC), Tandem t:slim X2 with Control-IQ Technology V1.5
- Where
- 3 sites in United States
- Volunteers
- 102 people
- Sponsor
- Marc Breton
Anemia
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
- Trial name
- NCT00548860
- Testing
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- Where
- United States
- Volunteers
- 2,018 people
- Sponsor
- American Regent, Inc.
Presyncope, Arrhythmias, Cardiac
The IPED (Investigation of Palpitations in the ED) Study
Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre-syncope (near blackout) are common ED problems sometimes due to an abnormal cardiac rhythm.
- Conditions
- Presyncope, Arrhythmias, Cardiac, Tachycardia, Supraventricular, Atrial Fibrillation
- Trial name
- IPED (NCT02783898)
- Testing
- AliveCor Heart Monitor
- Where
- 10 sites in United Kingdom
- Volunteers
- 243 people
- Sponsor
- NHS Lothian
Asthma
Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment
This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when…
- Trial name
- NCT03052517
- Testing
- QAW039 150 mg, QAW039 450 mg
- Where
- 347 sites in United States, Argentina and 40 more
- Volunteers
- 2,538 people
- Sponsor
- Novartis Pharmaceuticals
Acute Respiratory Distress Syndrome
KL₄Surfactant Treatment in Patients With ARDS
Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).
- Trial name
- NCT00215553
- Testing
- A.1 Lucinactant, B.3 SoC, A.2 Lucinactant
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Windtree Therapeutics
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD).
- Trial name
- NCT02476994
- Testing
- Clinolipid, Intralipid
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Baxter Healthcare Corporation
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid…
- Trial name
- NCT04555044
- Testing
- Clinolipid, Intralipid
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Depressive Disorder, Major
Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide
The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing…
- Trial name
- NCT03185819
- Testing
- Midazolam, Esketamine
- Where
- 51 sites in United States, Belgium and 7 more
- Volunteers
- 147 people
- Sponsor
- Janssen Research & Development, LLC
Burns
RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years
A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a…
- Trial name
- NCT03626701
- Testing
- RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device, Mepilex® Ag Wound Dressing, Conventional autografting (only when indicated)
- Where
- 9 sites in United States
- Volunteers
- 19 people
- Sponsor
- Avita Medical