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NCT ID: NCT01173601 Completed - Clinical trials for Major Depressive Disorder

A Fixed Dose Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder

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

The primary purpose of this study is to assess whether at least 1 dose of LY2216684 (12 milligrams [mg] or 18 mg once daily) is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI) during an 8-week, double-blind, acute adjunctive treatment phase.

NCT ID: NCT01172808 Completed - Asthma Clinical Trials

Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma I

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

The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.

NCT ID: NCT01170221 Completed - Clinical trials for Skin and Subcutaneous Tissue Bacterial Infections

TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.

ABSSSI
Start date: August 15, 2010
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Approximately 75 to 100 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment

NCT ID: NCT01167335 Withdrawn - Clinical trials for Partial Onset Seizures

Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

Start date: August 2010
Phase: Phase 2
Study type: Interventional

This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures

NCT ID: NCT01161524 Completed - Epilepsy Clinical Trials

A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents

Start date: September 2010
Phase: Phase 2
Study type: Interventional

This study is designed to investigate the short- and long-term effects of perampanel on cognition, growth, and development in adolescents.

NCT ID: NCT01152450 Completed - Asthma Clinical Trials

A Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Once Daily and Tiotropium 2.5 µg Twice Daily for Four Weeks in Patients With Moderate Persistent Asthma

Start date: July 2010
Phase: Phase 2
Study type: Interventional

Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent asthma. Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once daily (in the evening) or 2.5 µg tiotropium twice daily.

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: 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: NCT01136382 Completed - Asthma Clinical Trials

A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo

CHASE 1
Start date: July 2010
Phase: Phase 2
Study type: Interventional

This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to <12 years

NCT ID: NCT01131351 Terminated - Tuberculosis Clinical Trials

Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis

Start date: February 19, 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is: - To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background regimen of anti-TB medications (OBR). - To evaluate the pharmacokinetics (PK) of OPC-67683 and metabolites.