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NCT ID: NCT01090440 Completed - Schizophrenia Clinical Trials

Pharmacokinetics, Effect of Food, Safety and Tolerability of a New Tablet Formulation of GSK1144814 in Healthy Subjects

MNK112891
Start date: September 1, 2009
Phase: Phase 1
Study type: Interventional

GSK1144814 is a potent, insurmountable antagonist at human neurokinin-1 (NK1) and neurokinin-3 (NK3) receptors with the potential to treat multiple symptom domains of schizophrenia and be an efficacious antidepressant. This study will be an open label, randomised, three-way cross-over study to evaluate the safety, tolerability and pharmacokinetics of a new tablet formulation of GSK1144814 and to evaluate the effect of food on single oral doses of GSK1144814 in healthy male and female subjects.

NCT ID: NCT01090362 Completed - Atrial Fibrillation Clinical Trials

Global Anticoagulant Registry in the Field

GARFIELD-AF
Start date: December 21, 2009
Phase:
Study type: Observational

The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry) is a non-interventional, observational study that characterized a global population of non-valvular atrial fibrillation patients. The registry was used to document global baseline characteristics, current treatment strategies and outcome measures. Characterisation of a number of AF sub-populations was also completed. GARFIELD-AF is an independent academic research initiative sponsored by the Thrombosis Research Institute (London, UK) and supported by an unrestricted research grant from Bayer AG (Berlin, Germany).

NCT ID: NCT01089556 Completed - Clinical trials for Diabetic Neuropathy, Painful

A Study in Painful Diabetic Neuropathy

COMBO-DN
Start date: March 2010
Phase: Phase 3
Study type: Interventional

This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.

NCT ID: NCT01089452 Withdrawn - Hypertension Clinical Trials

Angiotensin Receptor Blocker Combined With Calcium Antagonist Evaluation of Safety and Lowering of Systolic Blood Pressure Study

ACCESS
Start date: n/a
Phase: Phase 4
Study type: Interventional

This study is looking to evaluate which drug combination, olmesartan/amlodipine or perindopril/amlodipine, is better at lowering blood pressure in people with mild to moderate hypertension. The investigators will be enrolling people who are either currently taking medication to lower their blood pressure or who have been recently diagnosed with high blood pressure and are not yet on medication. Patients on medication for their blood pressure will be asked to stop taking this medication for 2 to 4 weeks. If their blood pressure is suitable (not too high or low) they will be randomised to one of their treatment arm: Group 1 will receive Perindopril on its own (5mg for 4 weeks followed by 10mg for 8 weeks). There will be 80 patients in this group. Group 2 will receive Perindopril and Amlodipine together (5mg/5mg for 4 weeks, 10mg/5mg for a further 4 weeks then 10mg/10mg for the final 4 weeks). There will be 80 patient in this group. Group 3 will receive Olmesartan and Amlodipine together (20mg/5mg for 4 weeks, 40mg/5mg for a further 4 weeks then 40mg/10mg for the final 4 weeks). There will be 120 patients in this group. During the study we will measure the patients blood pressure and heart rate, weight and perform routine blood tests. They will also have ECGs (3 occasions) and 24 hour blood pressure monitor (4 occasions). At the end of the study patients pre-study medication will be restarted or they will be put on to a suitable alternative.

NCT ID: NCT01088984 Completed - Leukemia Clinical Trials

Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia

Start date: August 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of phase 1 of this study is to establish the recommended phase II dose (RP2D). The primary objective of phase 2 of this study is to evaluate the safety and efficacy of bendamustine at the recommended pediatric dose for the treatment of pediatric patients with relapsed or refractory acute leukemia.

NCT ID: NCT01088191 Completed - Osteoarthritis Clinical Trials

Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction

Start date: March 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety and preliminary efficacy of MSB-CAR001 in subjects who have recently undergone an Anterior Cruciate Ligament Reconstruction

NCT ID: NCT01087840 Completed - HIV Infections Clinical Trials

Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men

RAL-NPEP
Start date: July 2010
Phase: Phase 4
Study type: Interventional

The use of anti-HIV drugs following a potential sexual or injecting drug use exposure to HIV in order to try and prevent an exposure from becoming an infection is common. This is called nonoccupational postexposure prophylaxis (NPEP). The likelihood of NPEP succeeding is related to intrinsic qualities of the drugs used which includes at which point in the life cycle of the HIV virus the drugs work, how strong the drugs are against HIV, and how well tolerated the drugs are i.e. what side effects they produce. Many people skip doses during their treatment or abandon their treatment because of side effects. The anti-HIV drug raltegravir works early in the life cycle of the virus i.e. before it integrates with human DNA, is potent against HIV and causes few side effects. These qualities make it an obvious choice for use as a NPEP treatment. In this study 100 HIV negative men will receive raltegravir along with another HIV drug called truvada (commonly used in NPEP) for 28 days after a possible sexual exposure to HIV. They will be monitored closely for adverse events, side effects and for their ability to take the medicine each day for the whole 28 days. The hypothesis in this study states that raltegravir use in NPEP will be safe, well tolerated and result in a high treatment completion rate.

NCT ID: NCT01087502 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment

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

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).

NCT ID: NCT01087151 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Study of ABT-263 in Combination With Dose-Intensive Rituximab, or Dose-Intensive Rituximab Alone, in Previously Untreated Patients With B-Cell, Chronic Lymphocytic Leukemia (CLL)

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

This Phase II, randomized, open-label, international, multicenter trial is designed to evaluate the safety and efficacy of rituximab monotherapy when given according to a dose intense regimen and to assess the safety, efficacy, and pharmacokinetics of ABT-263 when combined with dose-intense rituximab in previously untreated patients with B-cell CLL.

NCT ID: NCT01086930 Completed - Spinal Cord Injury Clinical Trials

Early Intensive Hand Rehabilitation After Spinal Cord Injury

SCIPAHandsOn
Start date: September 2009
Phase: Phase 3
Study type: Interventional

Loss of hand function is one of the most devastating consequences of tetraplegia because of the severe impact on activities of daily living (ADL) and the resultant dependency on others. This multi-centre study in 78 participants will measure whether additional hand therapy provided via an electrical stimulator glove and specialised computer workstation improves hand function in people with tetraplegia.