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NCT ID: NCT03547583 Completed - Clinical trials for Chronic Heart Failure With Preserved Ejection Fraction

Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF

VITALITY-HFpEF
Start date: June 15, 2018
Phase: Phase 2
Study type: Interventional

The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.

NCT ID: NCT03547271 Completed - Clinical trials for Meningococcal Infections

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

Start date: December 14, 2018
Phase: Phase 3
Study type: Interventional

Primary objective is to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b [DTaP-IPV-HB-Hib vaccine]) to infants and toddlers 6 weeks to 18 months old Secondary objectives are: - To demonstrate the non-inferiority of the antibody (Ab) response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old. - To describe the Ab responses against meningococcal groups A, C, Y, and W and the antigens of the routine pediatric vaccines administered in the study.

NCT ID: NCT03547167 Completed - Clinical trials for Pneumococcal Infections

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)

Start date: July 16, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking or alcohol use, or 3) living in a community/environment with increased risk of disease transmission.

NCT ID: NCT03546907 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Start date: July 16, 2018
Phase: Phase 2
Study type: Interventional

Primary Objective: To investigate effects of SAR440340 (anti-interleukin-33 [IL-33] monoclonal antibody [mAb]) compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over up to 52 weeks of treatment. - Moderate exacerbations were recorded by the Investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. - Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Secondary Objectives: To investigate effects of SAR440340 compared with placebo, on improving respiratory function, as assessed by pre-bronchodilator forced exploratory volume in 1 second (FEV1). To evaluate effects of SAR440340 compared with placebo, on post-bronchodilator FEV1. To evaluate effects of SAR440340 compared with placebo, on duration from baseline to first moderate or severe AECOPD event. To evaluate effects of SAR440340 compared with placebo, on safety and tolerability.

NCT ID: NCT03545191 Completed - Insomnia Disorder Clinical Trials

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

Start date: June 4, 2018
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

NCT ID: NCT03544229 Completed - Clinical trials for Diabetic Gastroparesis

A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis

Start date: October 14, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of treatment with 2 dose levels of TAK-906 in adult participants with gastroparesis compared with placebo during 12 weeks of treatment.

NCT ID: NCT03543410 Completed - Depressive Episode Clinical Trials

A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression

Start date: June 26, 2018
Phase: Phase 2
Study type: Interventional

A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression

NCT ID: NCT03541174 Completed - Clinical trials for Resistant Hypertension

A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety

PRECISION
Start date: June 18, 2018
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs of patients with difficult to control (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is kept for long period of time.

NCT ID: NCT03539952 Completed - Wilson Disease Clinical Trials

Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease

Start date: September 3, 2018
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, open-label study with an active standard-of-care comparator (penicillamine)

NCT ID: NCT03537651 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation

Start date: April 25, 2018
Phase: Phase 3
Study type: Interventional

This study evaluates the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.