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NCT ID: NCT05643573 Terminated - Atrial Fibrillation Clinical Trials

A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke

OCEANIC-AF
Start date: December 5, 2022
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people with atrial fibrillation and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel). Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them. Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding. The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care with regard to the risk of bleeding. The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke. To see how well the study treatment asundexian works researchers compare: - how long asundexian works well and - how long apixaban works well after the start of the treatment. Working well means that the treatments can prevent the following from happening: - stroke and/or - systemic embolism. The study will keep collecting data until a certain number of strokes or embolisms happen in the study. To see how safe asundexian is, the researchers will compare how often major bleedings occur after taking the study treatments asundexian and apixaban, respectively. Major bleedings are bleedings that have a serious or even life-threatening impact on a person's health. The study participants will be randomly (by chance) assigned to 1 of 2 treatment groups, A and B. Dependent on the treatment group, the participants will either take the study treatment asundexian by mouth once a day or apixaban by mouth twice a day for approximately 9 - 33 months. Each participant will be in the study for approximately 9 - 34 months. There will be visits to the study site every 3 to 6 months and up to 7 phone calls. Those participants who do not want or are unable to have visits to the study site may join the study remotely in selected locations. The location name contains the abbreviation - DCT in such cases. During the study, the study team will: - take blood samples - do physical examinations - examine heart health using an electrocardiogram (ECG) - check vital signs such as blood pressure and heart rate - do pregnancy tests - ask the participants questions about their quality of life - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05603143 Terminated - COVID-19 Clinical Trials

Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness

BIRCH
Start date: November 5, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to test how well the study drug, obeldesivir (formerly GS-5245), works and how safe it is in treating coronavirus disease 2019 (COVID-19) in participants that have a higher risk of getting a serious illness.

NCT ID: NCT05593770 Terminated - COVID-19 Clinical Trials

International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response

NECTAR
Start date: October 27, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19.

NCT ID: NCT05568407 Terminated - Bladder Cancer Clinical Trials

A Study of Avelumab in Real-World Treatment for Patients With Advanced or Metastatic Urothelial Cancer

Start date: January 18, 2023
Phase:
Study type: Observational

This ambispective (both retrospective and prospective) NIS will evaluate the effectiveness and safety of Avelumab as a maintenance therapy administered after completion of first-line platinum-based chemotherapy in patients with locally advanced or metastatic urothelial cancer under routine conditions of daily clinical practice in Argentina and Brazil in line with the approved Avelumab label indication. Primary objective: • To evaluate overall survival (OS) rate at 12 and 24- months after the index date (date of the first Avelumab administration) in patients treated with Avelumab maintenance therapy. Secondary objectives: • To assess OS in patients treated with Avelumab maintenance therapy. To assess progression-free survival (PFS) of patients treated with Avelumab maintenance therapy. • To evaluate safety and tolerability of Avelumab maintenance therapy. • To assess duration of treatment (DOT) between the first and last dose of avelumab. • To describe the clinical and demographics characteristics of Argentinean and Brazilian patients treated with Avelumab maintenance therapy. Other objectives: • To evaluate anti-tumor effectiveness of Avelumab maintenance therapy.

NCT ID: NCT05540665 Terminated - Lupus Nephritis Clinical Trials

Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)

Start date: April 26, 2023
Phase: Phase 2
Study type: Interventional

Phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of daxdilimab in patients with active, proliferative lupus nephritis (LN).

NCT ID: NCT05490563 Terminated - Clinical trials for Spinocerebellar Ataxia Type 3

STRIDES - a Clinical Research Study of an Investigational New Drug to Treat Spinocerebellar Ataxia

STRIDES
Start date: June 3, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Phase 2b/3 double blind, randomized, placebo-controlled trial to assess safety and efficacy of SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) for the treatment of adults with spinocerebellar ataxia).

NCT ID: NCT05466240 Terminated - Dengue Fever Clinical Trials

Study of AT-752 in Patients With Dengue Infection

Start date: April 29, 2022
Phase: Phase 2
Study type: Interventional

The Phase 2 study will be conducted in adult patients with confirmed Dengue infection and will investigate safety, PK, and pharmacodynamics (PD) in this population. The study will be conducted in several dosing cohorts to enable dose selection for subsequent trials

NCT ID: NCT05451654 Terminated - COVID-19 Pandemic Clinical Trials

NanoMn®_COVID-19 A Prospective, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blind Trial to Evaluate the Clinical Efficacy of NanoManganese® on Top of Standard of Care, in Adult Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19)

Start date: February 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective, multicenter, randomized (3:1), placebo- controlled, parallel-group, double-blind trial. Patients will be randomized into two arms of treatment: - Placebo + SoC (N=30) - NanoManganese® + SoC (N=90) Patients will be treated and followed-up for 10 days: - Arterial oxygen partial pressure (PaO2) will be measured at baseline and at days 3, 5 and 10, - Oxygen saturation, vital signs including respiration rate, pulse rate, blood pressure and body temperature, disease severity (7-point ordinal scale and NEWS2 score) will be measured at baseline and daily, - Hematology and biochemistry measurements will be done at baseline and at day 3, 5 and 10, - Pharmacokinetic (Blood Mn concentration) measurements will be done at baseline and at day 3, 5 and 10, - Biomarkers will be measured at baseline and at day 3, 5 and 10. At the end of the 10-day treatment period, a follow-up visit will be planned between day 15 and day 22. The following. assessments/examinations will be performed: oxygen saturation, vital signs including respiration rate and body temperature, disease severity (7-point ordinal scale and NEWS2 score), electrocardiogram (ECG), hematology, biochemistry, concomitant therapies, and adverse events.

NCT ID: NCT05432908 Terminated - OSA Clinical Trials

Effect of Orofacial Myofunctional Therapy on Mouth Air Leak in Patients With Sleep Apnea Treated With CPAP

Start date: July 28, 2017
Phase: N/A
Study type: Interventional

To verify the effect of orofacial myofunctional therapy in patients with OSA during the use of CPAP with a nasal mask, on the frequency and leak flow. In addition, the impact on mouth opening frequency, sleep quality, perception of excessive daytime sleepiness, and CPAP adherence will be evaluated.

NCT ID: NCT05423327 Terminated - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Genetic Data Collection in Adult Participants to Identify Genetic Variants of Known Importance in Non-alcoholic Steatohepatitis (NASH)

Start date: December 9, 2021
Phase: N/A
Study type: Interventional

Collection of clinical and genetic data to help identify individuals that carry genetic variants of known importance in Non-alcoholic Steatohepatitis (NASH)