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NCT ID: NCT01442376 Completed - Clinical trials for Chemotherapy-Induced Nausea and Vomiting

Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients

Start date: September 2011
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in single and repeated chemotherapy cycles. The secondary objectives are to evaluate the safety and tolerability of IV palonosetron in pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of pediatric CINV patients.

NCT ID: NCT01440088 Completed - Soft Tissue Sarcoma Clinical Trials

A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

Start date: September 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma.

NCT ID: NCT01439971 Completed - Hemophilia A Clinical Trials

Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia

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

This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe to administer to subjects with severe Hemophilia A or B with or without inhibitors and will demonstrate evidence of hemostatic activity. This is supported by the preclinical findings in hemophilic animal models.

NCT ID: NCT01439880 Completed - Clinical trials for Hypercholesterolemia

Open Label Study of Long Term Evaluation Against LDL-C Trial

OSLER
Start date: October 7, 2011
Phase: Phase 2
Study type: Interventional

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

NCT ID: NCT01439100 Completed - Clinical trials for Parkinson's Disease With Severe Pain

A Randomised Placebo Controlled Study of OXN PR for Severe Parkinson's Disease Associated Pain

Start date: October 2011
Phase: Phase 3
Study type: Interventional

To demonstrate superiority of OXN PR compared to placebo with respect to analgesic efficacy in subjects with chronic severe pain associated with Parkinson's disease (PD), as assessed by averaged 24 hour pain scores collected for 7 days prior to the clinic visits

NCT ID: NCT01438489 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

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

The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.

NCT ID: NCT01437787 Completed - Clinical trials for Hematopoietic Neoplasm

Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis

JAKARTA
Start date: December 2011
Phase: Phase 3
Study type: Interventional

Primary Objective: - To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraindications for MRI). Secondary Objectives: - To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary. - To evaluate the Overall Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. - To evaluate the Progression Free Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. - To evaluate the durability of splenic response. - To evaluate the safety of IMP.

NCT ID: NCT01437735 Completed - Asthma Clinical Trials

Dose Finding Study for QAW039 in Asthma

Start date: August 2011
Phase: Phase 2
Study type: Interventional

This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging, multi-centre trial.

NCT ID: NCT01436162 Completed - Clinical trials for Major Depressive Disorder

Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

Start date: October 19, 2011
Phase: Phase 3
Study type: Interventional

This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD) who are taking certain types of antidepressants but continue to have residual depression symptoms. Eligible patients will remain on their antidepressant but will be randomized to either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study is to help answer the following questions: - How safe is SPD489 for the supplemental treatment of depression and what are the side effects that might be related to it? - Can supplemental SPD489 help patients who still have residual depression symptoms while taking an antidepressant? - How much SPD489 should be given to patients with depression who are also taking an antidepressant? - How does SPD489 compare to placebo in depressed patients who are also taking an antidepressant?

NCT ID: NCT01435616 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study in Patients With Type 2 Diabetes Mellitus

IMAGINE 2
Start date: November 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is: - To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. - To compare the rate of night time low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment. - To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment. - To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine after 52 weeks of treatment