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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.
Actively Recruiting
Researchers are conducting a Phase 1, open-label, dose escalation study to assess the safety, pharmacokinetics PK, and pharmacodynamics PD of an oral drug called AUR112 in patients with relapsed advanced lymphomas. This first-in-human trial aims to find safe and tolerable doses of AUR112 for future studies. The study is led by Aurigene Discovery Technologies Limited and focuses on patients with relapsed or refractory non-Hodgkin lymphoma NHL, chronic lymphocytic leukemia CLL, or Hodgkin disease who have exhausted other effective therapies. Participants will receive AUR112 once daily at increasing dose levels ranging from 100 mg to 1200 mg. The dose escalation follows a classic 33 design, where safety and biological activity data guide dose increases. The study will continue increasing doses until safety limits are reached or biologically active doses are identified. This approach helps determine the most appropriate doses for future clinical trials. During the study, participants will be closely monitored for dose-limiting toxicities and treatment-related adverse events over the first 28 days cycle 1. Researchers will also measure various PK parameters like maximum concentration, time to maximum concentration, and area under the curve on specific days. Assessments include laboratory tests, physical exams, and safety evaluations. The study will help identify doses for further research while ensuring participant safety throughout the trial period.