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NCT ID: NCT01578655 Completed - Prostate Cancer Clinical Trials

Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer

AFFINITY
Start date: August 2012
Phase: Phase 3
Study type: Interventional

This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.

NCT ID: NCT01575561 Completed - Bipolar I Disorder Clinical Trials

This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296

PERSISTExt
Start date: June 2012
Phase: Phase 3
Study type: Interventional

This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

NCT ID: NCT01575054 Completed - Muscle Spasticity Clinical Trials

BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity

Start date: May 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb spasticity.

NCT ID: NCT01573247 Terminated - Clinical trials for Acute Myeloid Leukemia

Safety Study of AKN-028 in Patients With Acute Myelogenous Leukemia

Start date: December 2011
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase 1/2 study consists of two parts. The purpose of Part 1 of the study is to examine the safety and tolerability of AKN-028 and to determine the recommended dose of AKN-028 for further evaluation in Part 2 of the study in patients with Acute Myelogenous Leukemia (AML). The purpose of Part 2 of the study is to determine safety and efficacy in patients with AML.

NCT ID: NCT01572727 Completed - Breast Cancer Clinical Trials

A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation

BELLE-4
Start date: August 2012
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate whether the addition of daily BKM120 to weekly paclitaxel is effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.

NCT ID: NCT01572402 Completed - Type 2 Diabetes Clinical Trials

Postprandial Insulin Secretion, Oxidative Stress and Gastrointestinal Peptides in Patients With Type 2 Diabetes Versus Healthy Subjects

Start date: January 2012
Phase: N/A
Study type: Interventional

Insulin secretion, plasma lipids, oxidative stress markers and gastrointestinal peptides will be measured in patients with type 2 diabetes versus healthy subjects in a fasting status and in response to standard meals (at times 0', 30', 60', 120' and 180').

NCT ID: NCT01568229 Terminated - Schizophrenia Clinical Trials

20110165: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms (Study 165)

Start date: May 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.

NCT ID: NCT01563978 Completed - Clinical trials for Rheumatoid Arthritis

Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis

Oskira ABPM
Start date: April 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of fostamatinib compared to placebo on ambulatory blood pressure in patients with active rheumatoid arthritis who are taking a disease-modifying anti-rheumatic drug (DMARD). The study will last for 57 days.

NCT ID: NCT01563263 Active, not recruiting - Clinical trials for Pseudomonas Aeruginosa Infection

Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43

Start date: March 2012
Phase: Phase 2/Phase 3
Study type: Interventional

This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.

NCT ID: NCT01561313 Completed - Clinical trials for Rheumatoid Arthritis

Crossover Study of Safety and Tolerability of Two Formulations of Adalimumab.

Start date: March 2012
Phase: Phase 2
Study type: Interventional

This study will compare injection site pain levels between current Humira® formulation versus a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either currently on a stable dose (minimum six consecutive doses) of on-label Humira or biological naïve who will be prescribed on-label Humira as treatment for their Rheumatoid Arthritis. The study is being conducted in two countries, Belgium (3 sites) and the Czech Republic (3 sites).