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NCT ID: NCT01354691 Completed - Dementia Clinical Trials

Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease

Start date: February 2011
Phase: Phase 2
Study type: Interventional

For many, Alzheimer's disease is the number one medical issue facing our aging society. It is a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory and cognitive performance. There are no known treatments that can either prevent or reverse its progression. Consequently, there still remains a need to evaluate treatments which can better stabilize the symptoms of this disease. These symptoms frequently include decreased functional capacity and negative psychological attributes (e,g, depression, anxiety) in association with the memory and cognition deficits. This current study is being done to assess an investigational compound that has been designed to not only improved the cognitive status of affected patients but to also better manage all symptoms. Hence, the ultimate goal is to provide patients with an improved quality of life by slowing the progression of this neurodegenerative disease

NCT ID: NCT01353625 Completed - Prostate Cancer Clinical Trials

Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.

Start date: April 25, 2011
Phase: Phase 1
Study type: Interventional

The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.

NCT ID: NCT01352845 Completed - Healthy Clinical Trials

A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.

B1971016
Start date: May 2013
Phase: Phase 3
Study type: Interventional

This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young adults. The study will also look at the safety of the new vaccine as well as how it is tolerated.

NCT ID: NCT01352793 Completed - Clinical trials for Meningitis, Meningococcal

A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

Start date: November 2012
Phase: Phase 3
Study type: Interventional

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2. All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

NCT ID: NCT01352741 Completed - Low Back Pain Clinical Trials

Comparison of Increasing Doses of Tapentadol Versus a Combination of Tapentadol and Pregabalin

Start date: March 2011
Phase: Phase 4
Study type: Interventional

The main objective of the study is to evaluate the effectiveness, safety, and tolerability of increasing doses of tapentadol prolonged release (PR) (500 mg per day) versus a combination of tapentadol PR (300 mg per day) and pregabalin (to 300 mg per day) in subjects requiring additional analgesia after titration to tapentadol PR 300 mg per day. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject reported outcomes. Since, severe low back pain with a neuropathic component, the targeted study population, is frequently treated with a combination therapy (monotherapy is often not effective enough) it is of interest to determine if tapentadol alone (combining 2 mechanisms of action in a single molecule) could be as effective as a combination of tapentadol plus pregabalin. Furthermore, the tolerability profiles of monotherapy versus combination are of interest.

NCT ID: NCT01352442 Completed - Presbyopia Clinical Trials

Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes

Start date: May 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will provide an effective method of for the correction of presbyopia in patients who have normal distance vision but need correction such as glasses or contact lenses to see clearly at near.

NCT ID: NCT01352273 Completed - Clinical trials for Advanced Solid Tumors

MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E Mutations

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

This is a multi- center, open-label, dose finding, Phase Ib study to be conducted in two stages: a dose escalation part to determine the maximum tolerated dose (MTD) safety and tolerability of concurrent administration of MEK162 and RAF265, followed by an expansion part to further assess the safety and preliminary anti-tumor efficacy of this oral combination within two separate patient populations: i) patients with advanced solid tumors harboring BRAFV600E mutations or ii) patients with advanced solid tumors harboring RAS mutations.

NCT ID: NCT01351818 Completed - Clinical trials for Growth Hormone Deficiency

Adipocyte Function and Somtropin Deficiency

FAYDS
Start date: May 2005
Phase: N/A
Study type: Observational

To assess the influence of exogenous GH (growth hormone) administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children with delayed growth due to GH deficiency. Study hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a regulatory effect on such hormones.

NCT ID: NCT01351415 Completed - Clinical trials for Non-Squamous Non-Small Cell Lung Cancer

A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

Start date: June 25, 2011
Phase: Phase 3
Study type: Interventional

This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.

NCT ID: NCT01350804 Completed - Clinical trials for Rheumatoid Arthritis

Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 1 Year of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents.

NURTURE 1
Start date: September 2011
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents.