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NCT ID: NCT05222529 Recruiting - Asthma Clinical Trials

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma

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

The purpose of this study is to characterize the bronchodilator effect, systemic exposure and safety/tolerability of two different doses of inhaled glycopyrronium, when compared to placebo. Outcome of this study will be used to determine the dose of inhaled glycopyrronium for the development of fixed dose combination indacaterol/mometasone/glycopyrronium (QVM149) for children aged 6 to less than 12 years old with moderate to severe asthma.

NCT ID: NCT05208944 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

THIO Sequenced With Cemiplimab in Advanced NSCLC

Start date: June 8, 2022
Phase: Phase 2
Study type: Interventional

THIO is a first-in-class small molecule telomere targeting agent, in development for the treatment of non-small cell lung cancer (NSCLC) in combination with cemiplimab (LIBTAYO®). THIO is preferentially incorporated into telomeres sequence in telomerase-positive cells leading to rapid telomere uncapping, genomic instability, and cell death. Cemiplimab is a programmed cell death protein 1 (PD-1) inhibitor recently approved as a first-line treatment for patients with locally advanced or metastatic NSCLC with 50% or more PD-L1 expression. It is hypothesized that THIO administration prior to cemiplimab would restore tumor responses to immunotherapy in subjects who either developed resistance or relapsed after receiving first line treatment with an immune check point inhibitor.

NCT ID: NCT05206539 Recruiting - Clinical trials for White Spot Lesion of Tooth

Efficacy of Different Agents in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children

Start date: June 1, 2024
Phase: Phase 3
Study type: Interventional

White spot lesions (WSL) are characterized by an apparently intact outer surface and a demineralized subsurface, and are considered the first clinical sign of dental caries. Aim of this study is to determine the treatment potential of self-assembling peptide (P11-4), casein phosphopeptide-amorphos calcium fluoride phosphate (CPP-ACFP) and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients using visual assessments and laser fluorescence investigation.

NCT ID: NCT05203341 Completed - Clinical trials for Major Depressive Disorder

Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)

SAVITRI
Start date: February 21, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of NBI-1065845 compared with placebo in participants with MDD on improving symptoms of depression.

NCT ID: NCT05202509 Active, not recruiting - Clinical trials for Atherosclerotic Cardiovascular Disease

Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease

PREVAIL
Start date: February 7, 2022
Phase: Phase 3
Study type: Interventional

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy.

NCT ID: NCT05201404 Recruiting - Clinical trials for Hepatocellular Carcinoma

Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis

LIVERATION
Start date: March 15, 2023
Phase: Phase 3
Study type: Interventional

This is a clinical trial in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh Class B7 (CPB7) cirrhosis whose disease has progressed on at least 1st-line therapy. The trial will evaluate the efficacy and safety of namodenoson as compared to placebo.

NCT ID: NCT05198310 Completed - Clinical trials for Arthritis, Rheumatoid

Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor

Start date: December 14, 2021
Phase: Phase 2
Study type: Interventional

Phase 2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of KPL-404 in subjects with moderate to severe Rheumatoid Arthritis.

NCT ID: NCT05192941 Active, not recruiting - Clinical trials for Hypercholesterolemia

Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia

V-DIFFERENCE
Start date: April 8, 2022
Phase: Phase 4
Study type: Interventional

Study of efficacy, safety, tolerability and quality of life of inclisiran (KJX839) vs placebo, on top of ongoing individually optimized lipid-lowering therapy, in participants with hypercholesterolemia

NCT ID: NCT05192382 Active, not recruiting - Acromegaly Clinical Trials

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)

PATHFNDR-2
Start date: December 17, 2021
Phase: Phase 3
Study type: Interventional

A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.

NCT ID: NCT05182840 Completed - Clinical trials for Kidney Disease, Chronic

A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease

Start date: January 11, 2022
Phase: Phase 2
Study type: Interventional

This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study. The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin. In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine. In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.