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NCT ID: NCT00089986 Completed - Sepsis Clinical Trials

GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults

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

The primary objective is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion.

NCT ID: NCT00088530 Completed - Clinical trials for Lymphoma, Non-Hodgkin

BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)

Start date: July 2004
Phase: Phase 3
Study type: Interventional

BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).

NCT ID: NCT00088465 Completed - Clinical trials for Schizoaffective Disorder

Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

Start date: August 2004
Phase: Phase 3
Study type: Interventional

This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot. Key objectives of the study are to: - Determine how well intramuscular (IM) olanzapine depot works during long-term treatment, - Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment, - Determine the blood levels of IM olanzapine depot in patients during long-term treatment

NCT ID: NCT00087711 Completed - Clinical trials for Non Small Cell Lung Carcinoma

A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Start date: July 2004
Phase: Phase 3
Study type: Interventional

This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

NCT ID: NCT00083304 Completed - Breast Cancer Clinical Trials

Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer

ENRICH
Start date: February 2004
Phase: Phase 3
Study type: Interventional

RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy. RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better. This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place.

NCT ID: NCT00082186 Completed - Clinical trials for Hypertension, Pulmonary

The Effect of Tracleer® on Male Fertility

Start date: July 2003
Phase: Phase 4
Study type: Interventional

The objective of the study is to evaluate the effects of chronic TRACLEER® treatment on testicular function via semen analysis in male patients with primary pulmonary arterial hypertension (PAH).

NCT ID: NCT00081796 Completed - Breast Cancer Clinical Trials

Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer

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

The purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.

NCT ID: NCT00081653 Completed - Clinical trials for Post-Menopausal Osteoporosis

A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

Start date: May 2004
Phase: Phase 4
Study type: Interventional

This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

NCT ID: NCT00081588 Completed - HIV Infection Clinical Trials

An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

Start date: November 2003
Phase: Phase 2
Study type: Interventional

The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.

NCT ID: NCT00081497 Completed - Fabry Disease Clinical Trials

A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease

Start date: January 2004
Phase: Phase 4
Study type: Interventional

People with Fabry Disease have an alteration in their genetic material (DNA) which causes a deficiency of the alpha-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that helps to break down and removes certain types of fatty substances called "glycolipids". These glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid (globatriaosylceramide or GL-3) levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study analyzed the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease that previously participated in the AGAL-008-00 (NCT0074984) study.