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NCT ID: NCT01396291 Completed - Bipolar 1 Disorder Clinical Trials

Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)

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

This study is being done to evaluate the efficacy and safety of asenapine as compared to placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic mixed episode in participants with Bipolar 1 Disorder. After a Screening Period, each participant will receive open-label asenapine and matching placebo for 12 to 16 weeks. Participants who meet stabilization criteria may then be randomized into one of the two study arms (asenapine or matching placebo) to receive double-blind treatment for up to an additional 26-weeks.

NCT ID: NCT01395810 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773

paradigm™ 4
Start date: April 15, 2012
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B. This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).

NCT ID: NCT01395017 Completed - Pancreatic Cancer Clinical Trials

Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

LAPC
Start date: June 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.

NCT ID: NCT01394952 Completed - Clinical trials for Diabetes Mellitus, Type 2

Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

REWIND
Start date: July 22, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.

NCT ID: NCT01393639 Completed - Clinical trials for Rheumatoid Arthritis

Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis

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

The purpose of this study is to compare the safety and efficacy of multiple doses of PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo in the treatment of rheumatoid arthritis. All subjects will also be receiving background treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for eight weeks followed by a 4 week period during which the dose of study medication will be gradually reduced. The efficacy of the study medications will be determined by assessing severity of the rheumatoid arthritis during the study and safety will be determined by adverse event reporting, laboratory tests and biomarker analysis.

NCT ID: NCT01392729 Completed - Renal Cell Cancer Clinical Trials

An Observational Study of Avastin (Bevacizumab) and Interferon Alpha 2a in Patients With Metastatic Renal Cell Cancer (VERA)

Start date: September 2010
Phase: N/A
Study type: Observational

This prospective observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with interferon alpha 2a in patients with previously untreated metastatic renal cell cancer. Data will be collected from each patient for up to 4 years.

NCT ID: NCT01392547 Completed - Clinical trials for Congenital Bleeding Disorder

Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors

adept™2
Start date: July 2011
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

NCT ID: NCT01392456 Completed - Clinical trials for Severe Atrophy of the Edentulous Mandible

Validation and Cross-Cultural Adaptation of the Romanian Version of Oral Health Impact Profile in Edentulous Adults

ROM-OHIP-ED
Start date: June 2004
Phase: N/A
Study type: Interventional

The aim of the study is: 1. To validate the Romanian translation of OHIP-EDENT (Oral Health Impact Profile in Edentulous Adults), the short form of OHIP (Oral Health Impact Profile) developed by Allen and Locker for edentulous adults. The OHIP questionnaire is an efficient instrument for assessment of OHRQoL - Oral Health-Related Quality of Life. 2. To compare satisfaction of 69 fully mandibular edentulous patients rehabilitated with implant-supported overdentures with three different types of retention: Retentive Anchors, Magnets, Locator.

NCT ID: NCT01392326 Completed - Psoriatic Arthritis Clinical Trials

Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)

FUTURE 1
Start date: September 2011
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

NCT ID: NCT01390649 Completed - Clinical trials for Immune Thrombocytopenic Purpura

A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)

Start date: November 2011
Phase: Phase 4
Study type: Interventional

It is known that intravenous immunoglobulins can induce hemolysis, but the mechanism is not known in detail. The primary objective of this study was to investigate the specificity of antigens on red blood cells in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of clinically relevant hemolysis following treatment with the intravenous immunoglobin Privigen®. The study was to explore potential mechanisms of hemolysis by analysis of the specificity of the antibodies possibly involved. To distinguish between clinically non-relevant hemolysis and a relevant intravascular hemolysis, an independent adjudication by a committee was performed for each patient with signs of hemolysis determined in the laboratory or in the clinic. This study was requested as a post-marketing commitment study by the United States Food and Drug Administration (FDA). By September 2014, no case of clinically significant intravascular hemolysis was found, and the FDA agreed to halt the study and analyze all hemolysis-relevant endpoints using FDA criteria for hemolysis in addition to analyses planned in the protocol. The study was not restarted.