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NCT ID: NCT04209543 Active, not recruiting - Vasomotor Symptoms Clinical Trials

Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)

Start date: December 30, 2019
Phase: Phase 3
Study type: Interventional

This is a two-part study designed to evaluate the effect of Estetrol (E4) 15 or 20 mg, or placebo on the severity and frequency of vasomotor symptoms (VMS) (Efficacy Study Part) and the safety of E4 20 mg (Endometrial and General Safety Study Part)

NCT ID: NCT04179175 Active, not recruiting - Clinical trials for Hidradenitis Suppurativa

Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

Start date: March 18, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this extension study is to evaluate maintenance of HiSCR response in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).

NCT ID: NCT04175600 Active, not recruiting - Clinical trials for Hypertension, Pulmonary

A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension

SALTO
Start date: January 16, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.

NCT ID: NCT04154956 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic

SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients

CARMEN-LC03
Start date: February 6, 2020
Phase: Phase 3
Study type: Interventional

Primary Objectives: - Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS]) - Study success is defined either on PFS or OS - The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) - The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: - To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel - To compare the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel - To evaluate the safety of tusamitamab ravtansine compared to docetaxel - To assess the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel

NCT ID: NCT04153149 Active, not recruiting - Clinical trials for Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Start date: November 26, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in patients with ATTR amyloidosis with cardiomyopathy.

NCT ID: NCT04082429 Active, not recruiting - Clinical trials for Haemophilia B Without Inhibitors

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors

explorer8
Start date: November 13, 2019
Phase: Phase 3
Study type: Interventional

This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B without inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group participants will get study medicine from the start of the study. In the other group participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will have to inject themselves with the study medicine 1 time every day under the skin. This can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for up to 6.5 years. The length of time the participant will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (21 April 2026 at the latest). Participants will have to come to the clinic for up to 40 times. The time between visits will be approximately 4 weeks for the first 6 to 12 months depending on the group participants are in, and approximately 8 weeks for the rest of the study. If the participant attends extra visits due to the prescription medicine not being available for purchase in their country, these will be 14 weeks apart. Participants will be asked to record information in an electronic diary during the study and may also be asked to wear an activity tracker.

NCT ID: NCT04027309 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy

HOVON 156 AML
Start date: December 20, 2019
Phase: Phase 3
Study type: Interventional

Activating mutations in the fms like tyrosine kinase 3 (FLT3) gene are observed in approximately 30% of patients with newly diagnosed acute myeloid leukemia (AML). Addition of the multitargeted kinase inhibitor midostaurin to standard chemotherapy prolongs event-free survival (EFS) and overall survival (OS) in patients with a FLT3 mutation. Gilteritinib is a more potent and more specific inhibitor of mutant FLT3 in comparison to midostaurin and has shown promising clinical activity in AML.

NCT ID: NCT03989206 Active, not recruiting - Clinical trials for Moderate-to-Severe Atopic Dermatitis

Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

Start date: December 30, 2019
Phase: Phase 3
Study type: Interventional

Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

NCT ID: NCT03915964 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis

RA-BRIDGE
Start date: April 25, 2019
Phase: Phase 4
Study type: Interventional

This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis.

NCT ID: NCT03872401 Active, not recruiting - Clinical trials for Coronary Heart Disease (CHD)

Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

VESALIUS-CV
Start date: June 11, 2019
Phase: Phase 3
Study type: Interventional

This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.