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NCT ID: NCT00354341 Completed - Anemia Clinical Trials

(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy

Start date: n/a
Phase: Phase 3
Study type: Interventional

This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

NCT ID: NCT00353678 Completed - Thromboembolism Clinical Trials

Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)

Start date: June 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.

NCT ID: NCT00353496 Completed - Endocrine Tumors Clinical Trials

Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours

CLARINET
Start date: June 2006
Phase: Phase 3
Study type: Interventional

The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.

NCT ID: NCT00351468 Completed - Clinical trials for Purpura, Thrombocytopaenic, Idiopathic

EXTEND (Eltrombopag Extended Dosing Study)

EXTEND
Start date: June 2006
Phase: Phase 3
Study type: Interventional

An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/microL will be investigated.

NCT ID: NCT00350207 Completed - Asthma Clinical Trials

Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

Start date: July 2006
Phase: Phase 2
Study type: Interventional

This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks. The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.

NCT ID: NCT00349895 Completed - Clinical trials for Coronary Artery Disease

Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth

Start date: August 2006
Phase: Phase 4
Study type: Interventional

This is a multi-center, prospective, non-randomized study. Approximately 90 patients from up to 16 centers will be entered in the study. Patients will be followed clinically for up to 5 years post-procedure. All patients will have a repeat angiography at 6 months follow-up. The primary objective of this study is to evaluate the safety and effectiveness of the Genous Bio-engineered R stentTM in conjunction with optimal statin therapy (80mg of atorvastatin), in the treatment of elective patients with up to two de novo native coronary artery lesions. The Genous stent received CE mark for the intended indication in August 2005

NCT ID: NCT00349310 Completed - Depression Clinical Trials

Profile of Depressive Symptoms in Parkinsons Disease

Start date: April 1, 2006
Phase:
Study type: Observational

To explore or establish the relationship between cognitive, mood and motor symptoms in PD to scores on depression rating scales in a naturalistic setting.

NCT ID: NCT00349141 Completed - Influenza Clinical Trials

Safety and Immunogenicity Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

Start date: June 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this study is to assess the safety and immunogenicity of 4 different doses of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine. Subjects will be enrolled sequentially into 3 study cohorts with 4 escalating doses of H5N1 hemagglutininin antigen (3.75 µg adjuvanted, 7.5 µg adjuvanted/non-adjuvanted, 15 µg adjuvanted/non-adjuvanted, 30 µg adjuvanted). Starting with the lowest dose level, subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review and evaluate all the safety data obtained for a dose level before allowing administration of the next (higher) dose.

NCT ID: NCT00348309 Completed - Alzheimer's Disease Clinical Trials

Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy For Subjects With Mild To Moderate Alzheimer's Disease

REFLECT-2
Start date: July 6, 2006
Phase: N/A
Study type: Interventional

Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG. This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with the currently approved AD medication, Aricept (donepezil). RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects their response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.

NCT ID: NCT00348283 Completed - Crohn's Disease Clinical Trials

Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon

Start date: August 2006
Phase: Phase 3
Study type: Interventional

The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.