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NCT ID: NCT01360866 Completed - Depression Clinical Trials

Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)

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

To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)

NCT ID: NCT01360853 Completed - Clinical trials for Metastatic Pancreatic Adenocarcinoma

Gemcitabine and ON 01910.Na in Previously Untreated Metastatic Pancreatic Cancer

ONTRAC
Start date: May 2011
Phase: Phase 3
Study type: Interventional

The question being asked in this study is: Will patients with advanced pancreatic cancer live significantly longer if they are treated with a combination of Gemcitabine and ON 01910.Na than if they are treated with Gemcitabine alone? There are two parts to this study. In the first part of the study, patients with metastatic pancreatic cancer who have received no prior chemotherapy for this disease will be assigned by chance either to the group that will be treated with both Gemcitabine and ON 01910.Na (about 100 patients will be in this group) or, to the group that will be treated with Gemcitabine only (about 50 patients will be in this group). How long patients survive in the 2 groups will be compared. If it looks like there is no difference between the groups, the study will stop. If it looks like patients in the group that were treated with both Gemcitabine and ON 01910.Na survive longer, the study will continue into a second part where more patients will be treated in order to confirm and better understand the findings of the first part of the study.

NCT ID: NCT01360840 Completed - Clinical trials for Prostate Cancer Metastatic

EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer

PERSEUS
Start date: April 2011
Phase: Phase 2
Study type: Interventional

The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

NCT ID: NCT01360632 Completed - Depression Clinical Trials

Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)

Polaris
Start date: June 2011
Phase: Phase 3
Study type: Interventional

To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT

NCT ID: NCT01360554 Completed - Clinical trials for Non-Small Cell Lung Cancer (NSCLC)

ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer

ARCHER 1009
Start date: June 2011
Phase: Phase 3
Study type: Interventional

This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.

NCT ID: NCT01360021 Completed - Asthma Clinical Trials

New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day

BAI
Start date: November 2011
Phase: Phase 3
Study type: Interventional

This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.

NCT ID: NCT01358357 Completed - Bipolar I Disorder Clinical Trials

Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

PERSIST
Start date: June 2011
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.

NCT ID: NCT01358084 Completed - Clinical trials for Advanced Malignant Pleural Mesothelioma

Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced MPM

NGR019
Start date: March 2011
Phase: Phase 2
Study type: Interventional

The main objective of the trial is to document the efficacy of NGR-hTNF administered as maintenance treatment at 0.8 µg/m2 weekly in advanced malignant pleural mesothelioma

NCT ID: NCT01356550 Completed - Healthy Volunteer Clinical Trials

A Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838

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

This open-label, single-dose, parallel group study will assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment. Patients and healthy volunteers will receive a single oral dose of RO4917838.

NCT ID: NCT01355627 Completed - Clinical trials for Cerebrospinal Fluid Leaks

TASALL - TachoSil® Against Liquor Leak

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

The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil® as an adjunct in sealing the dura mater. The trial population will consist of 726 randomised (1:1) patients elected for skull base surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1 weeks and safety follow-up 28±2 weeks after surgery.