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NCT ID: NCT00349284 Completed - Clinical trials for Hyperlipidemia Combined

A Controlled-Study of Fenofibrate 145 mg and Ezetimibe 10 mg in Type IIb Dyslipidemic Patients With Features of the Metabolic Syndrome

Start date: January 2005
Phase: Phase 3
Study type: Interventional

Type IIb dyslipidemia is characterized by elevated triglycerides (TG ³ 150 mg/dL), and elevated LDL-C levels (³160 mg/dL). When in addition, HDL-C is low, the presence of the lipid triad, elevated TG and LDL-C and low levels of HDL-C, seems to confer additional CHD risk in this type of patient, compared to elevated LDL-C alone.Coadministration of fenofibrate and ezetimibe could provide a complementary efficacy therapy and improve the atherogenic profile of this patient population.

NCT ID: NCT00349089 Completed - Clinical trials for Non Small Cell Lung Cancer

Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy

Start date: September 26, 2006
Phase: Phase 2
Study type: Interventional

The purpose of this randomized phase II trial is to determine the clinical feasibility - in terms of patients without dose limiting toxicities or premature treatment withdrawal or death - of the combination of Cisplatin and Pemetrexed and of the combination of Cisplatin and Vinorelbine. The combination of Cisplatin / Pemetrexed is assumed to be distinctly less toxic than Vinorelbine / Cisplatin.

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.

NCT ID: NCT00348140 Completed - Alzheimer's Disease Clinical Trials

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

REFLECT-3
Start date: July 2006
Phase: Phase 3
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 one of the currently approved AD medications, Aricept®, Razadyne® or Exelon®. 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 the 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: NCT00346723 Completed - Healthy Volunteers Clinical Trials

Annual Study to Investigate Inactivated Subunit Influenza Vaccine for the 2006/2007 Influenza Season in Europe.

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

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).

NCT ID: NCT00345800 Completed - Clinical trials for Narcolepsy With Cataplexy

Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes

Start date: April 10, 2006
Phase: Phase 1
Study type: Interventional

To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine changes.

NCT ID: NCT00345618 Completed - Thrombosis Clinical Trials

Clinical Study Assessing SSR126517E Injections Once-weekly in Pulmonary Embolism Therapeutic Approach

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

Objectives are to evaluate whether idrabiotaparinux (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.

NCT ID: NCT00343915 Completed - Hepatitis B Clinical Trials

Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

Start date: April 21, 2004
Phase: Phase 3
Study type: Interventional

To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course. Subjects were aged 11 to 15 years at the time of the primary vaccination course. At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00343824 Completed - Clinical trials for Burn Wounds - Partial Thickness (2nd Degree)

Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings

Start date: November 1, 2006
Phase: N/A
Study type: Interventional

This study is to compare the treatment with two different silver-containing wound dressings: aquacel AG hydrofiber versus acticoat burn dressing.

NCT ID: NCT00343720 Completed - Clinical trials for Non-Small Cell Lung Cancer

Study of Alimta® (Pemetrexed) Plus VELCADE® (Bortezomib) or Alimta Alone or VELCADE Alone in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior Therapy

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this study is to establish the objective response rate (complete response + partial response), following treatment with Alimta plus VELCADE, Alimta alone, or VELCADE alone in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior preventative therapy for Stage IIIb/IV NSCLC. The Alimta alone treatment group will be used as the control. The VELCADE single-agent treatment group will be used to determine if VELCADE administered weekly can demonstrate response rates.