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NCT ID: NCT01279213 Completed - Schizophrenia Clinical Trials

Clozapine/Paliperidone Versus Clozapine/Placebo in Resistant Schizophrenia

Start date: January 2009
Phase: Phase 4
Study type: Interventional

augmentation of clozapine with paliperidone in the treatment of resistant schizophrenia has not been tested until now in randomized controlled trials. This combination is supposed to have therapeutic efficacy in the treatment of resistant schizophrenia.

NCT ID: NCT01278290 Completed - Clinical trials for Central Precocious Puberty

Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls

Start date: December 2009
Phase: Phase 3
Study type: Interventional

The aim of the study is to determine the specificity, sensitivity and diagnostic efficiency of the Triptorelin Test in the assessment of CPP compared to GnRH test as gold standard. Hypothesis: Aqueous Triptorelin Acetate is so efficient as GnRH to CPP assessment. Study population are girls with suspicious clinical features of precocious puberty

NCT ID: NCT01277523 Completed - Asthma Clinical Trials

Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent Asthma

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

The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma. The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment. Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.

NCT ID: NCT01275066 Completed - MPS IV A Clinical Trials

A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)

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

This Phase 3 study will evaluate the efficacy and safety of 2.0 mg/kg/week BMN 110 and 2.0 mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A Syndrome). There is currently no standard accepted treatment for MPS IVA other than supportive care. Enzyme replacement therapy (ERT) may be a potential new treatment option for MPS IVA patients. BMN 110 is administered to MPS IVA patients by IV infusion, allowing cellular uptake by the mannose-6-phosphate receptor and transportation to the lysosomes. This enzyme uptake into the lysosomes is hypothesized to promote increased catabolism of keratan sulfate (KS) in tissue macrophages, hyaline cartilage, other connective tissues, and heart valve, and reduce the progressive accumulation of KS which is responsible for the clinical manifestations of the disorders.

NCT ID: NCT01274182 Completed - Clinical trials for Rheumatoid Arthritis

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Start date: January 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.

NCT ID: NCT01272219 Completed - Obesity Clinical Trials

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALEā„¢ - Obesity and Pre-diabetes

Start date: June 1, 2011
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America. The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline. Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).

NCT ID: NCT01271894 Completed - HIV Infection Clinical Trials

The Intensive Pharmacokinetics Sub-study of Encore1 (ENCORE1-PK)

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

Safety and efficacy are key issues in antiretroviral therapy (ART) selection. Efavirenz (EFV) is an important component of combination ART in treatment naive individuals. Like many drugs, there are inter-individual differences in the efficacy and tolerability of EFV. The Encore1 study provides an opportunity to examine the pharmacokinetics (PK)(processes by which a drug is absorbed, distributed, metabolized, and eliminated by the body) of EFV in blood samples collected over a 24-hour dosing interval in participants receiving either standard 600 mg or reduced 400 mg dose EFV once daily.

NCT ID: NCT01270464 Completed - Eosinophilic Asthma Clinical Trials

A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma

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

The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma.

NCT ID: NCT01268241 Completed - Fabry Disease Clinical Trials

The Efficacy and Safety of Switch Between Agalsidase Beta to Agalsidase Alfa for Enzyme Replacement in Patients With Anderson-Fabry Disease

SWITCH
Start date: December 2010
Phase:
Study type: Observational

The current approved treatment for Fabry disease is enzyme replacement therapy (ERT). There are actually 2 products in this therapeutic class available: Replagal® (agalsidase alfa) and Fabrazyme® (agalsidase beta). Both are indicated for long-term treatment in patients with a confirmed diagnosis of Fabry disease (alfa-galactosidase A deficiency). Both have been commercially available in Europe for almost 10 years, yet little information is available about the clinical and safety profile of patients who switch from one therapy to the other. An extended shortage of Fabrazyme® that began in June 2009 has necessitated that a large number of patients switch from Fabrazyme® to Replagal®. This offers the possibility to study the clinical status and adverse events in patients who switch from Fabrazyme® to Replagal® on a large-scale basis. In addition, as a result of the increasing Fabrazyme® shortage, many of these patients received a reduced dosage of Fabrazyme® for an extended period before transitioning to treatment with Replagal®.

NCT ID: NCT01266902 Completed - HIV-1 Infection Clinical Trials

A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1

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

The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.