Melsbroek, Belgium
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
Phase
3Span
119 weeksSponsor
Arrowhead PharmaceuticalsVictoria, Texas
Recruiting
Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
This is an event-driven study and will last until approximately 200 subjects have experienced a primary event, unless the study is stopped at the planned interim analysis. Visits after randomization will be performed as virtual visits where permissible every 3 months or as clinic visits until the study is stopped. For any subject prematurely discontinuing study medication, assessments will be conducted every 3 months for the collection of study endpoints. Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination or the presence of the AA genotype at variant rs 1967309 in the ADCY9 gene as determined by the investigational use only version of the cobas ADCY9 Genotype Test, conducted at a designated investigational testing site.
Phase
3Span
204 weeksSponsor
DalCor PharmaceuticalsVictoria, Texas
Recruiting
Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)
Phase
3Span
201 weeksSponsor
Anthos Therapeutics, Inc.Victoria, Texas
Recruiting
A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age
Part 1 will enroll participants aged 6 months to <6 years who have not been previously vaccinated against SARS-CoV-2. Participants will receive 2 doses of the mRNA-1273.214 vaccine. Part 2 will enroll participants aged 6 months to <6 years who have previously been vaccinated with a mRNA-1273 primary series in Study mRNA-1273-P204 (NCT04796896). Participants will receive a single BD of the mRNA-1273.214 vaccine, at least 4 months after completion of the mRNA-1273 primary series. Part 3 will enroll participants aged 6 months to <6 years who have previously been vaccinated with an authorized/approved COVID-19 vaccine. Participants will receive a BD of the mRNA-1273.815 vaccine at least 4 months after the last receipt of a COVID-19 vaccine. Part 4 will evaluate mRNA-1273.815 vaccine administered as a single dose to SARS-CoV-2 vaccine-naïve participants aged 2 years to <5 years of age enrolled in Cohort A (Part 4A), compared to 2 doses given to SARS-CoV-2 vaccine-naïve participants aged 6 months to <2 years enrolled in Cohort B (Part 4B).
Phase
3Span
175 weeksSponsor
ModernaTX, Inc.Victoria, Texas
Recruiting
Healthy Volunteers
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46) and does not require prior enrollment nor patient consent. The inclusion of the study's NCT number on MILD Medicare claims is required and results in enrollment.
Phase
N/ASpan
512 weeksSponsor
Vertos Medical, Inc.Victoria, Texas
Recruiting
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Phase
3Span
151 weeksSponsor
Teva Branded Pharmaceutical Products R&D, Inc.Victoria, Texas
Recruiting
A Study to Investigate the Effect on Lung Function of BDA Formulated With a New Propellant (HFO) Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma
The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma. The study duration for each participant will be approximately 14 to 15 weeks and will consist of: 1. A screening and placebo run-in period of approximately 2 weeks prior to the first dose of study intervention 2. 3 treatment periods of 4 weeks each 3. A final safety follow-up visit via telephone contact approximately 5 days after the final dose of study intervention Participants will attend in-clinic visits 2 weeks apart during the screening/run-in period (Visits 1 and 2) and then every 4 weeks during the treatment period (Visits 3, 4, and 5).
Phase
3Span
85 weeksSponsor
AstraZenecaVictoria, Texas
Recruiting
A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age
The study will be conducted in 2 parts: Part 1 Dose-Ranging and Part 2 Safety Expansion.
Phase
1/2Span
219 weeksSponsor
ModernaTX, Inc.Victoria, Texas
Recruiting
Healthy Volunteers
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Phase
2Span
156 weeksSponsor
AstraZenecaVictoria, Texas
Recruiting
A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma
Phase
3Span
77 weeksSponsor
Teva Branded Pharmaceutical Products R&D, Inc.Victoria, Texas
Recruiting