Aramil

Researchers are evaluating the effect of AZD0780 tablets on lowering low-density lipoprotein cholesterol (LDL-C) compared with placebo tablets, both given alongside rosuvastatin tablets, in adult Russian participants with dyslipidaemia. AZD0780 is a small molecule aimed at reducing LDL-C in the blood. This Phase II, randomized, double-blind, placebo-controlled study includes adults aged 18 or older with specific LDL-C levels and a history or risk of atherosclerotic cardiovascular disease (ASCVD). Participants will first go through a screening period of up to 14 days, followed by a 28-day run-in period taking rosuvastatin tablets. Then, they will be randomly assigned to receive either AZD0780 or placebo tablets once daily for 12 weeks, continuing rosuvastatin during this time. After treatment, there will be a 10-day safety follow-up. The study will be conducted at approximately 11 centers in Russia and plans to enroll about 76 participants. During the study, participants will undergo various assessments including fasting LDL-C measurements at baseline and after 12 weeks to evaluate the relative change. Safety and tolerability will also be monitored throughout. The total study duration for each participant is up to 136 days, including all periods. Researchers will use these data to understand the effects and safety of AZD0780 when combined with rosuvastatin.

Researchers are evaluating the effects of a combined treatment of zibotentan and dapagliflozin compared to dapagliflozin alone in adults with chronic kidney disease (CKD) who have high levels of protein in their urine. This Phase II, multicenter, randomized, double-blind study aims to assess the efficacy, safety, and tolerability of this combination on top of standard care, including participants with or without type 2 diabetes mellitus (T2DM). The study will provide important clinical data for potential approval of this combination treatment in the Eurasian Economic Union. Participants may undergo a 28-day run-in period with dapagliflozin if they are not already using SGLT2 inhibitors at screening. Following this, they will enter a 12-week double-blind treatment period where they receive either the fixed-dose combination of zibotentan/dapagliflozin or dapagliflozin monotherapy once daily. After completing the treatment phase, all participants will receive open-label dapagliflozin alone during a 4-week safety follow-up period. Throughout the study, researchers will monitor changes in urinary albumin to creatinine ratio (UACR) from baseline at week 12 to evaluate treatment effects. Participants will be assessed regularly for safety, tolerability, and efficacy, with clinical evaluations including laboratory tests and monitoring of adverse events. The total study participation includes the run-in period, 12-week treatment, and a 4-week safety follow-up, ensuring comprehensive observation of treatment impact and participant health.

Researchers are evaluating the rate of chronic kidney disease (CKD) diagnosis in adults with arterial hypertension (AH) who have laboratory markers indicating possible CKD but no prior recorded CKD diagnosis. The study focuses on patients without diabetes mellitus or symptomatic chronic heart failure and aims to better understand CKD prevalence in this specific population in Russia. This multi-center, non-interventional, observational study includes both prospective and retrospective data analysis involving about 10,000 adult outpatients from approximately 50 outpatient sites across 20 regions of Russia. The study will not involve any new diagnostic or treatment procedures beyond routine clinical practice. Retrospective data will be collected from medical records to identify CKD markers measured within 12 months before study inclusion. Patients with adequate retrospective data may have CKD diagnosis confirmed based on two evaluations at least 3 months apart. Those without sufficient retrospective data will undergo laboratory testing during the prospective study period, which will last up to 18 months or until data from 10,000 patients are collected. Participants will be monitored and treated by cardiologists or internal medicine specialists during routine visits. Researchers will collect demographic and clinical information, including medical history and CKD markers, from both retrospective and prospective records. The main outcome is the rate of new CKD diagnoses over the 18-month follow-up. No additional interventions or procedures beyond usual care will be performed, and the study aims to support earlier CKD detection and improved clinical outcomes in patients with hypertension.

Researchers are evaluating the effectiveness and safety of Raphamin in treating adults aged 18 to 75 years with acute rhinosinusitis, a condition characterized by symptoms such as facial pain and nasal congestion. This multicenter, double-blind, placebo-controlled, randomized clinical trial enrolls patients within 48 hours of symptom onset during the seasonal peak of acute respiratory viral infections. The study uses the Major Symptom Score (MSS) and Sino-Nasal Outcome Test (SNOT-22) to assess symptom severity and quality of life. Participants are randomly assigned to receive either oral Raphamin or a placebo following the same dosing schedule for five days. The trial includes a screening and randomization period of up to one day, a five-day treatment phase, and a follow-up period lasting up to 14 days. Patients attend three in-person visits on days 1, 4, and 7, with an additional phone visit on day 14. During these visits, symptom assessments, physical examinations, and diary reviews are conducted to monitor treatment adherence and safety. Patients keep an electronic diary twice daily to record body temperature and symptom changes according to the MSS. Investigators evaluate symptom progression, adherence, safety, and any complications including the use of antibiotics or hospitalizations. The primary outcome is the percentage of patients showing improvement in acute rhinosinusitis symptoms by day 4. Symptomatic and concomitant disease therapies are allowed except for prohibited medications. Overall, participants are observed for up to 14 days to assess treatment impact and safety.