Pan Jin Shi

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating the efficacy and safety of Antiwei granules for treating the common cold, specifically the wind-cold syndrome type. This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to assess how well Antiwei granules work and how safe they are for adults aged 18 to 65 who have had a recent onset of the common cold. Participants will be randomly assigned to receive either Antiwei granules or a placebo. Both groups will take oral doses of 1 sack (6g) three times daily for a total of 9 sacks over a 3-day treatment period. The study compares the effects of the active granules versus placebo on cold symptoms. During the trial, participants will be monitored closely with assessments focusing on the cure rate after 3 days of treatment. Researchers will track symptoms and safety throughout the short treatment period. The total study duration for each participant is about 3 days, during which the effectiveness and any side effects of the treatment will be recorded and analyzed.

Researchers are studying AZD1163, a new bispecific antibody, to assess its effectiveness and safety in adults with moderately-to-severely active rheumatoid arthritis (RA) who test positive for anti-citrullinated peptide antibodies (ACPA). This Phase II, randomized, double-blind, placebo-controlled trial involves participants already receiving standard treatments such as conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or tumor necrosis factor inhibitors (TNFi). Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a placebo, alongside their standard care, for 24 weeks. Following this treatment period, there will be a 28-week safety follow-up to monitor participants. Throughout the study, researchers will evaluate changes from baseline in disease activity scores using C-reactive protein levels at 12 weeks. Participants will undergo regular assessments including joint counts and laboratory tests to monitor disease status and safety. The total involvement in the study spans over 52 weeks, including treatment and follow-up periods.

Researchers are evaluating the efficacy and safety of a combination budesonide and albuterol metered dose inhaler (MDI) compared with an albuterol sulfate MDI in symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter, event-driven study aims to reduce the risk of severe asthma exacerbations in this population. The study will enroll approximately 790 participants who meet specific asthma-related eligibility criteria. The study includes three periods: a screening period of 14 to 28 days, a treatment period lasting at least 24 weeks and up to 52 weeks, and a safety follow-up period occurring about two weeks after the final visit. Participants will be randomly assigned to one of two treatment groups, receiving either the budesonide/albuterol MDI or the albuterol sulfate MDI as needed for asthma symptoms or before exercise, alongside their usual maintenance therapy. Participants will undergo assessments including lung function tests, asthma control questionnaires, and monitoring of severe asthma exacerbations throughout the treatment period. Researchers will track the time to the first severe asthma exacerbation as the primary outcome. Safety will be monitored during the follow-up period, and participants must demonstrate the ability to use the inhaler correctly and comply with study procedures throughout the trial.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

This research investigates the effectiveness of two different chemotherapy combinations as initial treatment for triple-negative breast cancer, which lacks three common receptors and tends to be aggressive with fewer treatment options. The study compares albumin-bound paclitaxel combined with carboplatin against epirubicin combined with docetaxel to see which works better before surgery. This trial is a multicenter, randomized, phase IV clinical study designed to improve treatment outcomes in patients with this challenging breast cancer subtype. Participants will receive one of two intravenous chemotherapy regimens. One group will get albumin-bound paclitaxel at 125 mg/m2 and carboplatin at AUC=2 mg·min/mL on days 1 and 8 within 21-day cycles, for a total of six cycles. The other group will receive epirubicin at 90 mg/m2 and docetaxel at 75 mg/m2 on day 1 every 21 days for four cycles. Carboplatin treatment includes hydration for three days before administration to protect kidney function. Throughout the study, participants will be regularly evaluated for treatment response, side effects, and overall health status. The main outcome measured is the rate of complete tumor remission five years after treatment. Researchers will monitor clinical lesions, organ function, and conduct routine blood tests to assess safety and efficacy. The study includes women aged 18 to 70 years with confirmed triple-negative breast cancer and clinically measurable tumors, ensuring thorough follow-up to assess long-term outcomes.

Researchers are conducting a multicenter, randomized, double-blind, phase III clinical trial to compare the effectiveness and safety of BAT5906 injection versus Lucentis® in patients with diabetic macular edema (DME). The study plans to enroll 406 adults aged 18 to 80 years with DME involving the macular center and specific retinal thickness and visual acuity criteria. The main goal is to measure changes in best-corrected visual acuity (BCVA) over 52 weeks to evaluate whether BAT5906 is not inferior to Lucentis®. Participants are randomly assigned in equal numbers to receive either BAT5906 injection at 4.0 mg per eye or Lucentis® at 0.5 mg per eye. Both treatments are given by intravitreal injection of 50 microliters per eye. Throughout the trial, participants undergo ophthalmic examinations and safety assessments following the study protocol. Blood samples are taken to assess immune responses. The study carefully monitors treatment effects and safety for one year. During the 52-week study, participants will have scheduled visits for eye exams, visual acuity testing using the ETDRS chart, and safety evaluations. Researchers will track changes in visual acuity as the primary outcome. Safety monitoring includes detailed eye assessments and blood tests. Participants must comply with study visits and procedures, and their overall health and eye condition will be closely observed throughout the trial period.

Researchers are evaluating the efficacy, safety, and tolerability of lunsekimig compared with a placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3 study focuses on patients with COPD who have specific lung function criteria, prior exacerbations, and blood eosinophil counts, aiming to better manage their condition using a new subcutaneous treatment. Eligible participants will receive subcutaneous injections of either lunsekimig or a matching placebo during a randomized intervention period lasting approximately 48 weeks. The study includes a screening period of up to 4 weeks before treatment and a follow-up period of about 8 weeks after treatment, making the total study duration up to 60 weeks. Participants remain in one of three study arms throughout this timeline. During the study, participants will be monitored regularly to measure the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will assess safety, tolerability, lung function, and other health outcomes. The study collects data on participants' lung function, exacerbation frequency, and blood markers, along with adherence to treatment and safety follow-up over the entire study period.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.