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NCT ID: NCT01901497 Completed - Clinical trials for Acute Respiratory Insufficiency

Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.

NIV-NEBU
Start date: July 2013
Phase: N/A
Study type: Interventional

The purpose of the study is to compare the pharmacokinetics of nebulized amikacin administered with three vibrating mesh nebulizers coupled with a single limb circuit bilevel ventilator in healthy volunteers. Following our previous in vitro study, our hypotheses are that the pharmacokinetics varies among the devices tested and that a most efficient device can be identified.

NCT ID: NCT01900652 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants

Chime
Start date: August 2013
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.

NCT ID: NCT01900574 Completed - Colitis, Ulcerative Clinical Trials

A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis

Start date: August 9, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with moderately to severely active Ulcerative Colitis (UC).

NCT ID: NCT01900028 Completed - Solid Tumours Clinical Trials

To Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib, and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients With Advanced Solid Tumours

Start date: October 2013
Phase: Phase 1
Study type: Interventional

This is a 3-part study in patients with advanced solid tumours: Part A will assess the effect of itraconazole on the PK parameters of olaparib and will determine the effect of olaparib on the QT interval following single oral dosing; Part B will determine the effect of olaparib on the QT Interval following multiple oral dosing; Part C will allow patients continued access to olaparib after the PK and QT phases and will provide for additional safety data collection. A total of 48 patients are planned to be enrolled; at least 42 evaluable patients will be required to complete the study. Patients will participate as a single cohort in all parts of the study.

NCT ID: NCT01899976 Completed - Clinical trials for Biliary Tract Cancer

X-MAS Biliary Study With Covered Biliary Stent

Start date: August 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered Biliary Metallic Stent for subjects with malignant stricture(s) in the biliary tree. The study is designed to support the regulatory requirement of a 510(k) marketing application in the United States.

NCT ID: NCT01898364 Completed - Pompe Disease Clinical Trials

Safety and Efficacy Evaluation of Repeat neoGAA Dosing in Late Onset Pompe Disease Patients.

Start date: August 19, 2013
Phase: Phase 1
Study type: Interventional

Primary Objective: To evaluate the safety and tolerability of neoGAA in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients. Secondary Objective: To evaluate the pharmacokinetics, pharmacodynamics of neoGAA in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients. To evaluate the effect of neoGAA on exploratory efficacy endpoints in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients.

NCT ID: NCT01897142 Completed - Healthy Clinical Trials

A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

Start date: September 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine what the study drug does to the body, what the body does to the study drug, and if the study drug is safe and well tolerated when given to adult healthy volunteers.

NCT ID: NCT01896232 Completed - Clinical trials for Chronic Kidney Disease

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Start date: August 13, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

NCT ID: NCT01895777 Completed - Clinical trials for Venous Thromboembolism

Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)

Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.

NCT ID: NCT01895543 Completed - Clinical trials for Chronic Idiopathic Constipation

Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

Echo 3
Start date: September 2013
Phase: Phase 3
Study type: Interventional

Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation