Criciuma

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effects of intranasal esketamine combined with comprehensive standard of care to rapidly reduce symptoms of major depressive disorder (MDD) in adolescents aged 12 to 17 years who have acute suicidal thoughts or behaviors. This phase 3 study compares esketamine plus standard care to a psychoactive placebo plus standard care to assess how well esketamine works in this urgent mental health condition. Participants will receive either esketamine as a nasal spray or a matching intranasal placebo, along with an oral solution of either midazolam or oral placebo. The treatments are given in a double-blind, randomized manner to ensure unbiased results. Esketamine is administered as an 84 mg nasal solution. The study focuses on the rapid reduction of depressive symptoms and suicidal ideation, with all participants receiving comprehensive standard care throughout the trial. During the study, researchers will measure changes in depressive symptoms using the Children's Depression Rating Scale - Revised (CDRS-R) at baseline before dosing and 24 hours after the first dose. Participants will be closely monitored for safety and clinical response, including assessments of suicidality severity. The study requires participants to be medically stable and hospitalized for acute suicidality at the start. Total participation duration is not specified but includes screening, treatment, and monitoring phases to evaluate rapid symptom changes.

Researchers are investigating a treatment approach for patients hospitalized with community-acquired pneumonia (CAP), a condition with high rates of illness and death. This phase 3 trial compares therapeutic-dose heparin versus usual care pharmacological thromboprophylaxis to see if it improves patient outcomes. The study focuses on preventing complications caused by blood clots and inflammation that can worsen respiratory and organ function in CAP patients. Previous findings in COVID-19 pneumonia suggest heparin might reduce disease progression and mortality, but its effects in non-COVID-19 CAP are unknown. Participants will receive either therapeutic-dose heparin, preferably a low molecular weight heparin (LMWH) like enoxaparin, dalteparin, or tinzaparin, dosed by patient weight unless contraindicated. Intravenous unfractionated heparin (UFH) may be used instead, especially for those with kidney issues, with dosing adjusted to specific blood clotting targets. The trial is open-label and randomized, with adaptive rules to monitor progress. Usual care pharmacological thromboprophylaxis is the comparator. Treatment and monitoring occur during hospital admission, anticipated to last at least 72 hours after randomization. During the study, patients are assessed for survival at 30 days and monitored for complications related to CAP. Researchers collect clinical data including oxygen use, laboratory tests, and adverse events, tracking safety and effectiveness. The study excludes patients with active COVID-19, recent bleeding, contraindications to anticoagulation, or those receiving critical care interventions. Overall participation depends on hospital stay length and clinical status, with follow-up to evaluate the primary outcome of survival within a month.

Researchers are evaluating the safety and effectiveness of paltusotine compared to a placebo in adults with carcinoid syndrome caused by well-differentiated neuroendocrine tumors. This Phase 3, randomized, double-blind, placebo-controlled study aims to further understand the safety, efficacy, and how the body processes paltusotine in these patients. Participants will be randomly assigned to receive either paltusotine or a placebo during a 16-week double-blind treatment period. The study includes a screening phase lasting up to 11 weeks, followed by a long-term open-label extension lasting 104 weeks, and concludes with a 4-week follow-up period. Paltusotine is taken orally once daily, and the study compares its effect to a matching placebo. During the study, participants will track the number of flushing episodes they experience each day in a diary to assess treatment effectiveness. Researchers will monitor safety and efficacy through regular assessments, including symptom recording and clinical evaluations throughout all study phases. The total participation time spans up to nearly 3 years, allowing for extended observation of long-term safety and benefits.

Researchers are conducting a phase IIb, double-blind, placebo-controlled study to evaluate the efficacy and safety of tozorakimab in adults with uncontrolled asthma who are already receiving medium-to-high doses of inhaled corticosteroids. This study aims to find the appropriate dose range of tozorakimab for this population, focusing on those with documented asthma for at least 12 months and evidence of uncontrolled symptoms. Participants will receive either tozorakimab or a placebo, both administered subcutaneously. The study compares different doses of tozorakimab against placebo, while all participants continue their current medium or high dose inhaled corticosteroids combined with long-acting beta-agonists (LABA). The treatment period and dosing schedule are designed to assess the drug's impact on asthma control and exacerbations. During the study, participants will be closely monitored through asthma daily diaries, lung function tests including pre-bronchodilator FEV1 measurements, and assessments of asthma control using the ACQ-6 score. Researchers will track the annualized rate of severe asthma exacerbations over 26 to 52 weeks. Safety and adherence will be evaluated, and women of childbearing potential will have pregnancy testing and must use contraception as per local regulations. Overall participation will involve regular visits to assess health status and response to treatment.

Septic shock is a serious condition marked by low blood pressure, reduced resistance in blood vessels, and poor response to drugs that constrict blood vessels, with nitric oxide playing a key role in this problem. Research shows that reduced response to certain medications is linked to changes in specific receptors and increased levels of a protein called GRK2, which nitric oxide helps raise. This study explores the idea that heart and blood vessel problems in sepsis may be caused by higher GRK2 activity, and that blocking this protein could be an effective treatment. The trial is evaluating paroxetine, given at a dose of 40 mg once daily for five days or until 24 hours after the shock resolves. Participants with septic shock will receive this medication or a placebo in a randomized, controlled setting to assess its effects on cardiovascular function. The study is a Phase 2 clinical trial designed to test whether paroxetine can regulate GRK2 expression and improve outcomes in septic shock. Participants will be followed for up to 28 days after enrollment, with the main measurement being the time until vasopressor medications can be stopped. Researchers will monitor heart and blood vessel function, drug usage, and overall health during this period. The study includes careful observation of safety and effectiveness to better understand paroxetine's potential role in treating septic shock.

Researchers are evaluating how well seltorexant works and its safety as an added treatment to antidepressants in adults and elderly participants who have major depressive disorder with insomnia symptoms (MDDIS). The study focuses on people who have not responded adequately to current antidepressant therapy with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This Phase 3 trial aims to assess the improvement of depressive symptoms and the maintenance effect of seltorexant compared to a placebo. Participants will receive either seltorexant or a matching placebo taken orally alongside their current antidepressant medication, which includes SSRIs or SNRIs. The study is divided into two parts: Part 1 evaluates changes in depression severity after 43 days, while Part 2 monitors the time to relapse for up to nearly three years in participants who achieved a stable response. Participants must continue their stable antidepressant dose during the study. During the study, participants will be assessed using the Montgomery-Asberg Depression Rating Scale to measure changes in depression symptoms and monitored for relapse over time. Safety and tolerability will also be evaluated throughout. The total participation includes an initial treatment phase and an extended maintenance phase, allowing researchers to understand both short-term and long-term effects of seltorexant as an adjunctive therapy.