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NCT ID: NCT00372944 Completed - Pancreatic Cancer Clinical Trials

AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy

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

The purpose of this study is to assess the efficacy and safety of AZD6244 (ARRY-142886)versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line therapy with gemcitabine. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or capecitabine. Treatment will be continued for as long as the patients receive clinical benefit. The status of all patients will be checked (whether they are still taking treatment or not) approximately 3 months after the last patient has entered the study.

NCT ID: NCT00371683 Completed - Pulmonary Embolism Clinical Trials

Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

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

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

NCT ID: NCT00369928 Completed - Clinical trials for Rheumatoid Arthritis

Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate

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

This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. After the washout period, patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.

NCT ID: NCT00366834 Completed - Nausea Clinical Trials

Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting

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

This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus dexamethasone and ondansetron is more effective in the prevention of vomiting than dexamethasone and ondansetron alone following the administration of moderately emetogenic chemotherapy.

NCT ID: NCT00366249 Completed - Diabetic Foot Clinical Trials

Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.

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

The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.

NCT ID: NCT00364182 Completed - Hemophilia B Clinical Trials

Study Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B

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

This study is designed to evaluate BeneFIX infused as prophylaxis regimens, compared with BeneFIX administered as an on-demand regimen only. In the trial, subjects will participate in 4 study periods. The first period is a 16-week on-demand treatment, during which subjects will utilize BeneFIX to treat bleeding events episodically only as they occur (i.e., on-demand treatment). At the end of this period, subjects will be randomly assigned to 1 of 2 BeneFIX prophylaxis regimens: either 100 IU/kg once weekly or 50 IU/kg twice weekly, and followed for 16 weeks. At the end of this period, subjects will use on-demand treatment for 8 weeks. The purpose of this 8-week period is to mitigate the potential carry-over effect of the prior prophylaxis regimen on bleeding frequency. Following this 8-week on-demand treatment, subjects will cross-over and receive the alternate study prophylactic regimen for 16 weeks. The primary endpoint is annualized number of bleeding episodes, compared between the first on-demand period and each of the prophylaxis regimens. A comparison of annualized bleeding episodes between the two prophylaxis regimens will also be performed. Subject-reported outcomes will also be collected using a patient diary. At 24 and 48 hours following the onset of each joint bleeding episode, information on pain, sleep, and work will be collected. Additional data on physical functioning will be recorded on the diary at the end of the 16-week on-demand period, and at the end of each prophylaxis period. Information on safety will also be collected. Each subject will participate in this study for approximately 59 weeks (15 months), including a screening period of up to 3 weeks, an initial 16-week on-demand period, two prophylaxis treatment periods of 16 weeks each, separated by an 8-week on-demand treatment period. A modified FIX recovery study will be performed once during each prophylaxis period. The study diary will also be used by subjects to collect secondary endpoints. These endpoints, which are subject-reported outcomes, will be recorded in the diary at 24 and 48 hours following the onset of each joint bleeding episode. Additional data on physical functioning will be recorded on the diary at the end of the 16-week on-demand period, and at the end of each prophylaxis period. Patients will be recruited in the United States, Canada, Europe and Russia.

NCT ID: NCT00363896 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

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

To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

NCT ID: NCT00363415 Completed - Clinical trials for Small Cell Lung Cancer

Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer

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

This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.

NCT ID: NCT00362323 Completed - Clinical trials for Dyslipidemia/Glucose Metabolism Disorder

Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

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

To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a statin and receiving metformin, the superiority of a fixed combination of fenofibrate and metformin vs metformin alone on TG and additionally, if the superiority on TG is established, to demonstrate the superiority on HDL-C

NCT ID: NCT00361335 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

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

The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated.