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NCT ID: NCT00399009 Terminated - Rectal Cancer Clinical Trials

Comparative Study of Circular Stapling Instruments

Start date: January 2004
Phase: N/A
Study type: Interventional

After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of surgical circular stapling instruments. In a retrospective pilot study the risk of developing an acute leak in the anastomosis was increased with one of the most commonly used instruments in Sweden as compared to the other brand in use. In the current study the patient is randomized to either one of the instruments after a resection of the rectum for rectal cancer.

NCT ID: NCT00398905 Completed - Clinical trials for Venous Thromboembolism

Dose-Ranging Study of BAY 59-7939 on the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

ODIXa-HIP2
Start date: January 2004
Phase: Phase 2
Study type: Interventional

Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE. The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied by injections below the skin. The purpose of this study was to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug enoxaparin and to find the optimal dose of BAY 59-7939 for the anticipated phase III trials. Enoxaparin, a so-called low molecular weight heparin, is approved and widely used in the area of thromboprophylaxis and was given once daily subcutaneously. In this study 5 different doses of the investigational drug BAY 59-7939 were tested in comparison to Enoxaparin. The following doses of BAY 59-7939 were tested: 2.5 mg twice daily (5 mg total daily dose); 5 mg twice daily (10 mg total daily dose), 10 mg twice daily (20 mg total daily dose), 20 mg twice daily (40 mg total daily dose) and 30 mg twice daily ( 60 mg total daily dose). This study ran for approximately 7 months in a number of countries. In total, 726 patients were enrolled in this study.

NCT ID: NCT00397722 Completed - Social Phobia Clinical Trials

Treatment Of Patients With Social Anxiety Disorder

Start date: November 9, 2006
Phase: Phase 2
Study type: Interventional

GW876008 is a drug which may change mans reaction to stress, by decreasing the fear, physical and behavior symptoms that people with SocAD experience in social situations.

NCT ID: NCT00396877 Completed - Clinical trials for Heart Defects, Congenital

Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation

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

Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important. The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig Shunt [BTS]). The secondary objective was to assess the safety of Clopidogrel in the study population.

NCT ID: NCT00396786 Completed - Clinical trials for Venous Thromboembolism

Dose-ranging Study of Once-daily Regimen of BAY 59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

ODIXaHIP-OD
Start date: November 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess different doses of a new drug (BAY 59-7939), taken as a tablet, are safe and can help prevent blood clots forming after a hip replacement operation. Patients undergoing hip replacement surgery are at risk of developing blood clots. To reduce this risk treatment to prevent clots forming is routinely given. The current treatments can include injections under the skin or other treatments that need frequent blood tests to monitor levels of drug in the body. Therefore there is a need for new drugs, which are easier to give and need less monitoring.

NCT ID: NCT00396591 Completed - Ovarian Neoplasms Clinical Trials

AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites

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

The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites. The secondary objectives were to further assess efficacy and safety of Aflibercept treatment, and the exploratory objectives were to assess pharmacokinetics, immunogenicity and health-related quality of life.

NCT ID: NCT00396448 Terminated - Obesity Clinical Trials

Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.

Start date: February 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults

NCT ID: NCT00395772 Completed - Clinical trials for Venous Thromboembolism

Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis

Start date: December 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.

NCT ID: NCT00394277 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C

Start date: February 2007
Phase: Phase 4
Study type: Interventional

This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

NCT ID: NCT00393939 Completed - Breast Neoplasms Clinical Trials

Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer

SUN 1064
Start date: February 2007
Phase: Phase 3
Study type: Interventional

This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.