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NCT ID: NCT02304484 Completed - Clinical trials for Hypercholesterolemia

Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab

Start date: November 24, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.

NCT ID: NCT02299505 Completed - Clinical trials for Non-Small Cell Lung Cancer

Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)

Start date: April 9, 2015
Phase: Phase 1
Study type: Interventional

A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC)

NCT ID: NCT02296138 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.

Start date: January 13, 2015
Phase: Phase 3
Study type: Interventional

The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

NCT ID: NCT02294877 Completed - MPS IVA Clinical Trials

A Multicenter, Multinational, Observational Morquio A Registry Study (MARS)

MARS
Start date: September 2014
Phase:
Study type: Observational [Patient Registry]

The objectives of this program are: to characterize and describe the Mucopolysaccharidosis IV type A (MPS IVA) population as a whole, including the heterogeneity, progression, and natural history of MPS IVA; to evaluate the long-term effectiveness and safety of Vimizim®, including, but not limited to, the occurrence of serious hypersensitivity reactions, anaphylaxis, and changes in antibody status; to help the medical community with the development of recommendations for monitoring MPS IVA patients and reports on patient outcomes to optimize patient care; to collect data on other treatment paradigms, and evaluate the prevalences of their use and their effectiveness; to characterize the effects and safety of Vimizim treatment 5 years from enrollment in the Registry for patients under 5 years of age; to monitor pregnancy exposure, including maternal, neonatal, and infant outcomes; and to monitor patients who have completed the MOR-005 and MOR-007 clinical trials. These patients will be encouraged to enroll in the applicable Registry Substudy and will be monitored using the MOR-005 and MOR-007 assessment schedules, respectively.

NCT ID: NCT02287584 Completed - Schizophrenia Clinical Trials

Confirmatory Study of DSP-5423P in Patients With Schizophrenia

Start date: December 2014
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.

NCT ID: NCT02278536 Completed - Trisomy 21 Clinical Trials

Multiple Gestation Study

Start date: March 2013
Phase:
Study type: Observational

The objectives of the clinical study are to demonstrate the accuracy of our new NATUS diagnostic method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. The long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than any currently available screening tests. This will result in fewer unnecessary amniocenteses and CVS procedures, which are associated with a risk of miscarriage.

NCT ID: NCT02278120 Completed - Clinical trials for Advanced Metastatic Breast Cancer

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

MONALEESA-7
Start date: November 20, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.

NCT ID: NCT02277990 Completed - Clinical trials for CIED Related Infection

World-wide Randomized Antibiotic Envelope Infection Prevention Trial

WRAP-IT
Start date: January 2015
Phase: Phase 4
Study type: Interventional

Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.

NCT ID: NCT02276313 Completed - Atherosclerosis Clinical Trials

BIOLUX P-III All-Comers Passeo-18 Lux Registry

Start date: October 2014
Phase:
Study type: Observational

BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.

NCT ID: NCT02275897 Completed - Pregnancy Clinical Trials

Effect of Different Injection Speeds for Spinal Anaesthesia in Caesarean Section

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

The purpose of this study is to investigate if prolonging the speed of injection during spinal anaesthesia can reduce the incidence of hypotension and/or medication requirements thereby making it safer for the mother and foetus.