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NCT ID: NCT03653364 Completed - Influenza Clinical Trials

Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms

Start date: January 23, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to <1 year with influenza like symptoms

NCT ID: NCT03639571 Completed - Healthy Clinical Trials

Phase I Study to Assess Irritation, Sensitization and Adhesion of a Novel Ibuprofen 200 mg TEPI Medicated Plaster

Start date: August 9, 2018
Phase: Phase 1
Study type: Interventional

This trial will be conducted with the aim to investigate the dermal response (skin irritation, sensitization) and the adhesion of Ibuprofen 200 mg TEPI Medicated Plaster as compared to a Placebo TEPI Plaster in two phases: Induction Phase: multiple dose application of one active and one placebo plaster on 5 consecutive days in which the plasters remain in place for 23 hours ± 30 min a day and Challenge Phase: single dose application of one active and one placebo plaster which remain in place for 48 hours ± 30 min.

NCT ID: NCT03629782 Completed - Severe Asthma Clinical Trials

Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy

RECOGNISE
Start date: April 26, 2018
Phase:
Study type: Observational

This is a multi-country, multicentre, observational cross-sectional one-visit study of patients suffering from severe asthma in primary and secondary care settings in Europe

NCT ID: NCT03627767 Completed - Dermatitis, Atopic Clinical Trials

Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

Start date: June 11, 2018
Phase: Phase 3
Study type: Interventional

B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.

NCT ID: NCT03623321 Completed - Clinical trials for Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Start date: July 17, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of pimavanserin in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease exposed to open-label pimavanserin for up to 52 weeks.

NCT ID: NCT03622580 Completed - Clinical trials for Diabetic Macular Edema

A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)

Start date: September 5, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

NCT ID: NCT03622112 Completed - Asthma Clinical Trials

A Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD7594 Administered Once Daily by Inhalation in Asthmatic Subjects

Start date: January 2, 2019
Phase: Phase 2
Study type: Interventional

This study will assess the efficacy and safety of multiple dose levels of AZD7594 administered once daily (QD) by inhalation in a 12-week treatment period on asthma subjects. The activity will be assessed by comparing AZD7594 to placebo. The comparison between active comparator (FF) and placebo will be used for bench marking. The efficacy is assessed by the evaluation of change in trough forced expiratory volume in 1 second (FEV1). The aim is to develop AZD7594 as a once daily inhaled non-steroidal selective GR modulator (SGRM), which may ultimately lead to better disease control of both chronic obstructive pulmonary disease (COPD) and asthma through improved efficacy and compliance. The overall rationale for developing a once daily AZD7594 in a dry powder inhaler (DPI) is to provide a safe and effective future treatment option for both asthma and COPD subjects.

NCT ID: NCT03621280 Completed - Cushing Syndrome Clinical Trials

Open-label Treatment in Cushing's Syndrome

OPTICS
Start date: January 7, 2019
Phase: Phase 3
Study type: Interventional

This is a long-term, open-label extension study of levoketoconazole in subjects with endogenous Cushing's Syndrome.

NCT ID: NCT03619213 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.

DELIVER
Start date: August 27, 2018
Phase: Phase 3
Study type: Interventional

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.

NCT ID: NCT03606408 Completed - Cushing's Syndrome Clinical Trials

Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699

Start date: October 5, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is the evaluation of long-term safety of osilodrostat in patients who have already received osilodrostat treatment in a previous Global Novartis-sponsored trial and who, based on investigators' judgement, will continue benefiting with its administration.