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NCT ID: NCT00713830 Completed - Clinical trials for Diabetes Mellitus, Type 2

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea

GETGOAL-S
Start date: July 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to sulfonylurea without or with metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to sulfonylurea with or without metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than (<) 7 percent (%); percentage of patients reaching HbA1c less than or equal to (<=) 6.5%; body weight; fasting plasma glucose (FPG); beta-cell function assessed by homeostasis model assessment (HOMA) beta; 2-hour postprandial plasma glucose (PPG), glucagon, insulin, proinsulin, and C-peptide after a standardized meal challenge test in a sub-study in all patients in selected centers; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

NCT ID: NCT00713661 Completed - Clinical trials for Colorectal Anastomosis

Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)

Start date: June 2008
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe. The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials.

NCT ID: NCT00713427 Completed - Clinical trials for Biliary Strictures Caused by Malignant Neoplasms

Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Start date: July 2007
Phase: N/A
Study type: Interventional

This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.

NCT ID: NCT00712933 Completed - Clinical trials for Systemic Lupus Erythematosus

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

Start date: May 30, 2008
Phase: Phase 3
Study type: Interventional

This is a long-term continuation study to provide continuing treatment to subjects with SLE.

NCT ID: NCT00711893 Completed - Heart Failure Clinical Trials

Feature Assessment Study for Indications Based Programming

FASt-IBP
Start date: June 2008
Phase: N/A
Study type: Observational

The purpose of this evaluation is to assess the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications when using the feature 'Indications Based Programming' (IBP) available in the ZOOMVIEW Software Application for the TELIGEN DR / VR and COGNIS family of devices compared to daily life programming chosen by physicians.

NCT ID: NCT00711503 Completed - Type 1 Diabetes Clinical Trials

Anti-Interleukin-1 in Diabetes Action

AIDA
Start date: January 2009
Phase: Phase 2/Phase 3
Study type: Interventional

A draw trial of the effect of Interleukin-1 Receptor Antagonist (anakinra, Kineret®) on the insulin production in patients with new onset Type 1 diabetes. Kineret® is already being used in the treatment of patients suffering from rheumatoid arthritis and preclinical studies are now suggesting that it may also be useful for patients with Type 1 diabetes. The active substance in Kineret is interleukin-1 receptor antagonist, a blocker of an immune-signal molecule named interleukin-1. The trial is a blinded randomised trial, in which the patient is allocated to receive the active drug (Kineret®) or placebo (saline). The hypothesis is that anti-IL-1 treatment as add-on therapy to conventional insulin therapy will preserve or enhance beta-cell function.

NCT ID: NCT00711295 Completed - Influenza Clinical Trials

Phase 3 Study of a H5N1 Vaccine in Adults, Elderly and Specified Risk Groups

Start date: August 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of, and the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult and elderly population and in specified risk groups. Furthermore, persistence of H5N1 influenza antibodies after vaccination with this vaccine will be assessed.

NCT ID: NCT00710749 Completed - Clinical trials for Lower Urinary Tract Symptoms

The Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects

Start date: July 2008
Phase: N/A
Study type: Interventional

Crossover comparison of different flow meters with a digital home flow meter as a reference. Main hypothesis: Reapeated home flow measurements with a disposable device will provide a better understanding of the patients urinary flow than a single measurement performed in the clinic.

NCT ID: NCT00710515 Completed - Melanoma Clinical Trials

Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies

Start date: July 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test if the levels of AZD6244 in blood are affected by taking food at the same time as the capsules compared to taking capsules on an empty stomach

NCT ID: NCT00710294 Completed - Hypertension Clinical Trials

Device Based Therapy in Hypertension Extension Trial

DEBuT-HET
Start date: August 2005
Phase: N/A
Study type: Interventional

This clinical investigation is designed to describe the long-term safety and efficacy of the CVRx Rheos Baroreflex Hypertension Therapy System in patients who participated in the DEBuT-HT study beyond the original follow up period (4-months or longer). The information obtained in this trial is intended to support regulatory approvals and market release of this therapy.