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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: NCT01083693 Completed - Clinical trials for Rheumatoid Arthritis

Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs

Start date: September 2008
Phase: N/A
Study type: Observational

The aim of this post-marketing observational study is to obtain further data on the evaluation of quality of life outcomes of HUMIRA® in routine clinical use in patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) after unsustainable clinical response to disease modifying antirheumatic drugs (DMARD) and or biological disease modifying antirheumatic drugs (BDMARD). Treatment strategies in moderate to severe rheumatoid arthritis, psoriatic arthritis and in severe active ankylosing spondylitis commonly consist of introducing biologics after conventional disease modifying antirheumatic drugs or non steroidal antiinflammatory drugs fail. Although biologic disease modifying antirheumatic drugs are generally well-tolerated, intolerances may develop or efficacy may diminish, at which time another biologic disease modifying antirheumatic drug might be considered. This study shall evaluate the quality of life outcomes of HUMIRA®, given after conventional disease modifying antirheumatic drugs and or non antiinflammatory drug failures and or after biological disease modifying antirheumatic drug failures . Failure in this context means primary or secondary loss of efficacy or intolerance to the initial agent.

NCT ID: NCT01082874 Completed - Clinical trials for Cardiovascular Disease

PeriOperative ISchemic Evaluation-2 Trial

POISE-2
Start date: July 2010
Phase: Phase 3
Study type: Interventional

Major surgeries not involving the heart are common, and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of surgery have been tested. There is encouraging data suggesting that small doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications, given individually for a short period before and after major surgeries may prevent major heart problems. The POISE-2 Trial is a large international study to test if ASA and Clonidine can prevent heart attacks and deaths from heart problems around the time of surgery.

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: NCT01080391 Completed - Clinical trials for Relapsed Multiple Myeloma

Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

Start date: July 14, 2010
Phase: Phase 3
Study type: Interventional

The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.

NCT ID: NCT01078701 Completed - Influenza, Human Clinical Trials

Dose Finding Study of Single Dose GHB11L1 in Healthy Adults

GHB-CS07
Start date: December 2009
Phase: Phase 2
Study type: Interventional

The purpose of this phase IIa trial is to evaluate the immunogenicity of a single dose of GHB11L1 administered by liquid nasal spray for vaccination against influenza A (H1N1) virus. This study is also performed to assess safety, tolerability and pharmacokinetics (shedding) of a single dose of GHB11L1 administered by liquid nasal spray.

NCT ID: NCT01077362 Completed - Clinical trials for Arthritis, Psoriatic

A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents

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

The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.

NCT ID: NCT01077271 Completed - Premature Infants Clinical Trials

Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA

Start date: October 2008
Phase: N/A
Study type: Observational

Compliance to Synagis (palivizumab) is a key factor to obtain maximal protection against respiratory syncytial virus (RSV) infection as shown in the IMpact study. Many factors such as parents' knowledge of burden of respiratory syncytial virus disease or physicians' satisfaction with Synagis as well as the appropriate use of the product might influence compliance. The primary objective of this observational study is to evaluate the compliance to Synagis under daily pediatricians practice conditions in premature infants 33 to 35 weeks gestational age (wGA). Palivizumab, monoclonal antibody for passive immunoprophylaxis against severe respiratory syncytial virus disease, was administered according to usual clinical practice. Compliance was assessed using four criteria: The number of injections per participant per respiratory syncytial virus season, the body site where injections were administered, the interval in days between injections, and the dosage per administration. Originally the study was to include two respiratory syncytial virus seasons but was extended to a third season.

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