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NCT ID: NCT01147250 Completed - Clinical trials for Acute Coronary Syndrome

Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

ELIXA
Start date: June 2010
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate that lixisenatide can reduce cardiovascular morbidity and mortality [composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina] compared to placebo in type 2 diabetic patients who recently experienced an acute coronary syndrome (ACS) event. Secondary Objectives: To demonstrate that when compared to placebo, lixisenatide can reduce: - composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure - composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure - urinary albumin excretion (based on the urinary albumin/creatinine ratio). To assess the safety and tolerability of lixisenatide.

NCT ID: NCT01146652 Completed - Clinical trials for Rheumatoid Arthritis

Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)

Start date: June 21, 2010
Phase: Phase 3
Study type: Interventional

Main Study: Primary Objective: Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA). Secondary Objective: Assess the long term efficacy of sarilumab in participants with RA. Sub-Study: This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by participants with moderate or severe RA, or their professional or non-professional healthcare providers in an unsupervised real-world situation. To mimic the real-world practice, the sub-study was incorporated into the LTS11210 study without additional visits compared to the scheduled visits in the main study. The duration of this sub-study was 12 weeks.

NCT ID: NCT01144338 Completed - Clinical trials for Type 2 Diabetes Mellitus

Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus

Start date: June 18, 2010
Phase: Phase 3
Study type: Interventional

This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.

NCT ID: NCT01142674 Completed - Clinical trials for Lymphoma, T-Cell, Peripheral

T-Cell Project: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma

Start date: September 2006
Phase:
Study type: Observational

The designed study follows up the retrospective previous one by the International T-cell Non-Hodgkin's Lymphoma Study Group (International Peripheral T-Cell Lymphoma Project). It is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed patients with the more frequent subtypes of Peripheral T-cell lymphoma (Peripheral T-cell lymphoma unspecified and Angioimmunoblastic T-cell lymphoma) and to better define clinical characteristics and outcome of the more uncommon subtypes

NCT ID: NCT01142193 Completed - Epilepsy Clinical Trials

Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures

Start date: May 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.

NCT ID: NCT01129882 Completed - Schizophrenia Clinical Trials

An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia

ASPIRE
Start date: June 24, 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to continue to provide aripiprazole intramuscular (IM) depot treatment (400 milligrams [mg] or 300 mg) to participants with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248. In addition, the secondary objective was to collect additional long-term safety data on aripiprazole IM depot treatment.

NCT ID: NCT01128881 Completed - Hemophilia B Clinical Trials

IMMUNINE Pre-Treatment Study

Start date: May 31, 2010
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to prospectively document the exposure to IMMUNINE and to monitor FIX inhibitors over a period of approximately 20 to 50 exposure days while receiving prophylactic treatment in up to 50 previously treated patients (PTPs) aged 12-64 years and approximately 20 pediatric PTPs up to 11 years of age with severe (FIX level < 1%) or moderately severe (FIX level <= 2%) hemophilia B who are planned to enter BAX326 study 250901, provided all eligibility criteria are met. In addition, this study will evaluate the efficacy, safety, immunogenicity, thrombogenicity, and health-related quality of life (HR QoL) of these subjects.

NCT ID: NCT01125566 Completed - Breast Neoplasms Clinical Trials

LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

Start date: June 22, 2010
Phase: Phase 3
Study type: Interventional

To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

NCT ID: NCT01112306 Completed - Clinical trials for Pulmonary Arterial Hypertension

ACT-293987 in Pulmonary Arterial Hypertension

Start date: July 7, 2010
Phase: Phase 3
Study type: Interventional

Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

NCT ID: NCT01110408 Terminated - Clinical trials for Complicated Urinary Tract Infections or Pyelonephritis

A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections

Start date: December 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with complicated urinary tract infections.