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NCT ID: NCT01651104 Completed - Human Influenza Clinical Trials

Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects

Start date: July 2012
Phase: Phase 2
Study type: Interventional

To evaluate the safety of a single intramuscular (IM) injection of trivalent adjuvanted influenza study vaccine, formulation 2012/2013, in elderly subjects and the antibody response to each influenza vaccine antigen, as measured by single radial hemolysis (SRH) and hemagglutination inhibition (HI) at approximately 21 days postimmunization in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.

NCT ID: NCT01650597 Completed - Healthy Volunteers Clinical Trials

A Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-42165279 in Healthy Male Participants

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

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single ascending doses as well as repeated doses of JNJ-42165279 in healthy male participants.

NCT ID: NCT01650441 Completed - Asthma Clinical Trials

Study to Assess the Effect of the NEXThaler® Device (DPI - Dry Powder Inhaler) on the Central and Peripheral Airway Dimensions in Asthmatic Patients

Start date: April 2012
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate in a dry powder inhaler (NEXThaler®) on central and peripheral airway dimensions in asthmatic patients. Therefore Computational Fluid Dynamics (CFD) will be used. Further more, the effect of this combination therapy on lung function (spirometry, resistance and diffusion), the Asthma Control Test (ACTâ„¢) and the Asthma Control Questionnaire (ACQ) will be assessed and the safety will be evaluated.

NCT ID: NCT01650246 Completed - Gout Clinical Trials

Open-Label Lesinurad Monotherapy Extension Study in Gout

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

This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.

NCT ID: NCT01649856 Completed - Clinical trials for Lymphoma, Large B-Cell, Diffuse

A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma

Start date: August 24, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.

NCT ID: NCT01649778 Completed - Clinical trials for Carcinoma, Renal Cell

Observational Study of Real World Effectiveness Data and Safety in Patients Receiving Pazopanib With Advanced or Metastatic Renal Cell Carcinoma

PRINCIPAL
Start date: July 19, 2012
Phase:
Study type: Observational

This is a global, multi-centre, long-term, prospective, observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated for the first time with pazopanib. The study is designed to enroll approximately 700-1000 patients in over the course of an enrollment period of approximately 18 months.There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 30 months or until premature discontinuation (i.e., due to death, withdrawal of consent, lost to follow-up or study termination).

NCT ID: NCT01649518 Completed - Clinical trials for Osteoarthritis, Knee

A Measurement of Knee Osteoarthritis Usual Care

Start date: November 2012
Phase: N/A
Study type: Observational

Osteoarthritis is the most common affection of joints worldwide. Multiple international guidelines on the approach and treatment of knee osteoarthritis are available. Nevertheless there seems to be a gap between usual care and the preferred one. A vigorous set of evidence-based quality indicators on osteoarthritis diagnosis and therapy was developed by a multidisciplinary expert team. This project aims to map usual care and to explore the gaps between usual care and international guidelines in a second stage. This will enable us to develop a tightly targeted quality improvement intervention later on.

NCT ID: NCT01649102 Completed - Clinical trials for Catheter Related Bloodstream Infection

Impact of Catheter Design on Catheter Survival in Chronic Hemodialysis Patients

Start date: March 2010
Phase: Phase 4
Study type: Interventional

The trial aims to compare the performance of two tunneled cuffed catheters (TCC) in chronic hemodialysis patients. The design of the catheter may affect the propensity for thrombosis and hence intraluminal infection, as well the percentage of recirculation and hence the efficiency of dialysis.

NCT ID: NCT01648140 Completed - Clinical trials for Hepatitis C, Chronic

Dose Ranging of GSK2336805 in Combination Therapy

HAI115879
Start date: August 2012
Phase: Phase 2
Study type: Interventional

GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being developed for the treatment of chronic HCV infection. This Phase II, multicenter, parallel-group, randomized, dose-ranging study will assess the safety and tolerability, antiviral activity, and pharmacokinetics of GSK2336805 at 2 dose levels (40 and 60 mg) in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA) in approximately 100 treatment-naïve subjects with chronic genotype 1 HCV infection. In a separate nonrandomized single-arm cohort, up to 15 treatment-naïve subjects with genotype 4 chronic HCV infection will be enrolled in parallel at the dose level of 60 mg of GSK2336805.

NCT ID: NCT01647516 Completed - Ulcerative Colitis Clinical Trials

Efficacy and Safety Study of Ozanimod in Ulcerative Colitis

Touchstone
Start date: December 26, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).