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NCT ID: NCT00452530 Completed - Pulmonary Embolism Clinical Trials

Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

ADVANCE-2
Start date: June 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.

NCT ID: NCT00451932 Completed - Clinical trials for Liver Transplantation

A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant Patients

Start date: October 2002
Phase: Phase 2
Study type: Interventional

A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.

NCT ID: NCT00451451 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis

CONFIRM
Start date: June 2007
Phase: Phase 3
Study type: Interventional

To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse. Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.

NCT ID: NCT00451126 Completed - Clinical trials for Psychological Stress

Moderating Impact of Various Emotion Personality Factors on Salivary Cortisol Response to a TSST

cortpersonal
Start date: October 2005
Phase: N/A
Study type: Observational

With the aim of evaluating the putative impacts of emotion related personality factors on physical and mental disease and the mechanisms of these impacts, 58 students were submitted to a social stress test (Trier Social Stress Test) and salivary cortisol samples were taken. The subjects were also submitted to several personality trait inventory, that evaluated respectively Alexithymia, Emotional Intelligence, Resilience and the Five Factor Model of Personality. The moderating impact of these factors on the cortisol response were analysed

NCT ID: NCT00450892 Completed - Breast Cancer Clinical Trials

Phase I/II Study of Neoadjuvant Lapatinib in Breast Cancer

Start date: February 2007
Phase: Phase 1/Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of docetaxel and lapatinib when given with or without combination chemotherapy and to see how well they work in treating women with locally advanced, inflammatory, or resectable breast cancer.

NCT ID: NCT00450580 Completed - HIV-1 Infection Clinical Trials

HIV-1 Infection Study of Once a Day Versus Twice a Day Protease Inhibitor in Antiretroviral Treatment Naive Adults

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

This is a Phase IIIB, 48 Week, multicentre, randomized, open-label, parallel group study comparing the safety and efficacy of fosamprenavir plus ritonavir 1400mg/100mg once-daily to fosamprenavir plus ritonavir 700mg/100mg twice-daily, both administered with abacavir/lamivudine 600mg/300mg once-daily in antiretroviral-naive HIV-1 infected adults. This study utilizes a group-sequential design with two stages: 1) an interim 24 week cohort analysis of approximately 200 subjects and 2) if study continuation criteria are met at this interim analysis, further enrolment of an additional 528 subjects, followed over a minimum of 48 weeks. The objectives of the study are to demonstrate 1) non-inferior antiviral activity of fosamprenavir/ritonavir 1400mg/100mg QD compared to fosamprenavir/ritonavir 700mg/100mg BID and 2) a superior fasting non-HDL lipid profile in subjects receiving fosamprenavir/ritonavir 1400mg/100mg QD.

NCT ID: NCT00449033 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)

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

Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00448305 Completed - Breast Neoplasms Clinical Trials

EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

Start date: January 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy, safety and tolerability of a therapy with EndoTAG-1 + paclitaxel in combination and EndoTAG-1 alone as a rescue therapy for patients with relapsed or metastatic triple receptor negative breast cancer (a special subgroup of breast cancer).

NCT ID: NCT00448058 Completed - Depressive Disorder Clinical Trials

A Study Of New Medicine (GSK 372475) For The Treatment Of Depression

Start date: April 2007
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)

NCT ID: NCT00447278 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents

ADHD LIFE
Start date: March 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder [ADHD]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.