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NCT ID: NCT01808573 Completed - Clinical trials for HER2+ Metastatic Breast Cancer (MBC)

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

NALA
Start date: March 29, 2013
Phase: Phase 3
Study type: Interventional

This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.

NCT ID: NCT01808131 Completed - Gout Clinical Trials

Lesinurad and Allopurinol Combination Extension Study in Gout

Start date: February 2013
Phase: Phase 3
Study type: Interventional

This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.

NCT ID: NCT01807949 Completed - Clinical trials for Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

TRANSPORT
Start date: April 2013
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

NCT ID: NCT01807520 Completed - Clinical trials for Moderate to Severe Nail Psoriasis

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis

TRANSFIGURE
Start date: June 20, 2013
Phase: Phase 3
Study type: Interventional

This purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.

NCT ID: NCT01807455 Completed - Acne Scars Clinical Trials

An Open, Non-comparative Study of the Efficacy and Safety of Treatment of Acne Scars With Restylane Vital Lidocaine

Start date: April 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital Lidocaine when acne scars are treated

NCT ID: NCT01806844 Completed - Cardiac Arrest Clinical Trials

Prehospital Cerebral Oxygenation During Cardiopulmonary Resuscitation (CPR)

Start date: May 2013
Phase: N/A
Study type: Observational

Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Beer-Lamber law, a numeric result can be calculated. During a cardiac arrest, there is no stroke volume, no cardiac output and no cerebral perfusion. By using cerebral NIRS during out-of hospital cardiac arrest, low flow time and return of spontaneous circulation, this study wants to show the prognostic value of NIRS as extra monitoring.

NCT ID: NCT01806597 Completed - Clinical trials for Moderate to Severe Palmoplantar Psoriasis

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis

GESTURE
Start date: June 19, 2013
Phase: Phase 3
Study type: Interventional

Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab.

NCT ID: NCT01806259 Completed - Clinical trials for Inflammatory Positive/Negative Status

Ketorolac in Breast Cancer Surgery

KBCt
Start date: February 2013
Phase: Phase 3
Study type: Interventional

Do the use of Ketorolac in one intravenous injection at the moment of the operative incision reduce the number of recurrence in patient with advanced breast cancer without inflammation signs.

NCT ID: NCT01805284 Completed - Pneumonia Clinical Trials

Pharmacokinetic and Pharmacodynamic Evaluation of Linezolid Administered Intravenously in MRSA-positive, Morbidly Obese Patients With Pneumonia

UGENT_LIMOP
Start date: February 2013
Phase: Phase 4
Study type: Interventional

The objectives of the study are: (i) to evaluate the proportion of patients who attain a T>MIC (Minimum Inhibitory Concentration) of 100% and the time frame in which they do so. The investigators therefore plan to measure unbound linezolid trough concentrations before administration of the second, third, fourth and fifth dose. Furthermore, the investigators will assess the AUC0 - 24h/MIC in all study subjects. Therefore, multiple plasma samples will be drawn after the fourth or fifth dose, when steady state conditions are reached. (ii) to describe the pharmacokinetic variability of unbound linezolid concentrations in this cohort using a population pharmacokinetic model and to assess the expected probability of target attainment (PTA) by MIC against MRSA. Twenty adult, MRSA-positive, morbidly obese patients with clinically and radiologically documented pneumonia are to be included. Therefore, a multi-centre, international observational study is necessary. Given the specific target population this study is not feasible in a single-centre approach. The goal is to find up to 6 centres that anticipate including 3 to 4 patients in the study within a time frame of one year. Included patients should receive at least 6 doses of linezolid. Linezolid must be administered intravenously (iv) over a one hour controlled infusion (with use of a volumetric infusion pump).

NCT ID: NCT01803555 Completed - Asthma Clinical Trials

Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®

Start date: July 4, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) Spiromax 160/4.5 micrograms (mcg) is as effective as Symbicort Turbohaler 200/6 mcg administered twice daily in participants with persistent asthma.