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NCT ID: NCT01096186 Completed - Parkinson's Disease Clinical Trials

An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease

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

The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

NCT ID: NCT01083732 Completed - Clinical trials for Venous Thromboembolism

Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age

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

To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data

NCT ID: NCT01081834 Completed - Clinical trials for Diabetes Mellitus, Type 2

The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

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

The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.

NCT ID: NCT01081769 Completed - Schizophrenia Clinical Trials

Prevention of Relapse With Injectable Paliperidone Palmitate Versus Oral Antipsychotics

PROSIPAL
Start date: February 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy (how well the drug works; primarily through the time to relapse) of long-acting injectable paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over 24 months in the treatment of recently diagnosed (1-5 years since diagnosis) schizophrenia.

NCT ID: NCT01081678 Completed - Fracture Healing Clinical Trials

Study To Assess FRacTure Healing With SclerosTin Antibody - Hip

STARTT-Hip
Start date: June 20, 2010
Phase: Phase 2
Study type: Interventional

This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.

NCT ID: NCT01076764 Completed - Clinical trials for Acute Coronary Syndrome

Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy

TAO
Start date: April 2010
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide Secondary Objectives: - To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide - To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide - To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide - To document the safety of Otamixaban as compared to UFH + eptifibatide - To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide

NCT ID: NCT01069900 Completed - Clinical trials for Intraabdominal Infections

Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

MOXIPEDIA
Start date: July 21, 2010
Phase: Phase 3
Study type: Interventional

The primary focus of the study is the evaluation of the safety of treatment with moxifloxacin in a pediatric population 3 months to <18 years old. Approximately 450 pediatric subjects with a complicated intra-abdominal infection will be enrolled in the study and treated with either moxifloxacin intravenously and orally if switched to oral therapy or ertapenem (intravenously) and, if switched to oral therapy, amoxicillin/clavulanate.

NCT ID: NCT01069705 Completed - Clinical trials for Pseudomonas Aeruginosa

Second Open Label Extension to Bridging Study CTBM100C2303

Start date: February 12, 2010
Phase: Phase 3
Study type: Interventional

This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.

NCT ID: NCT01067521 Completed - Clinical trials for Relapsing Remitting Multiple Sclerosis

A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo

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

The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in subjects with RRMS, as measured by the number of confirmed relapses during the 12 month placebo controlled period. The study has two periods: - Placebo Controlled Period: 12 months of 40 mg administered three times a week by subcutaneous injection or matching placebo. - Open Label Extension Period: All subjects will continue treatment with GA 40 mg administered three times a week, until this dose strength is commercially available for the treatment of relapsing remitting multiple sclerosis (RRMS) patients or until the development of this GA dose regimen is stopped by the Sponsor

NCT ID: NCT01065038 Completed - Clinical trials for Essential Thrombocythaemia

Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia

ANAHYDRET
Start date: September 2002
Phase: Phase 3
Study type: Interventional

Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®)was not inferior to HU with respect to efficacy in patients with ET. This approach to demonstrate non-inferiority was based on the following decision points: • ET is a rare disease and recruitment of large patient number (> 1600) to prove superiority was not considered possible. . It was decided to recruit only treatment naïve high risk patients to avoid pre-treatment bias, which further limited the number of patients eligible for the study.