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NCT ID: NCT00625898 Terminated - Breast Cancer Clinical Trials

BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab

BETH
Start date: April 2008
Phase: Phase 3
Study type: Interventional

The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer.

NCT ID: NCT00625664 Completed - Clinical trials for Urinary Bladder Neoplasms

Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer

CILAB
Start date: February 2008
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.

NCT ID: NCT00624780 Completed - Clinical trials for Generalized Anxiety Disorder

Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder

Start date: May 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).

NCT ID: NCT00624338 Completed - Clinical trials for Lupus Erythematosus, Systemic

Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)

APRIL-SLE
Start date: January 2008
Phase: Phase 2/Phase 3
Study type: Interventional

This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.

NCT ID: NCT00623727 Terminated - Hemophilia A Clinical Trials

BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

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

A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.

NCT ID: NCT00623597 Completed - HIV Infections Clinical Trials

A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.

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

This single arm study will assess the pharmacokinetics, safety and activity of saquinavir (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination with ritonavir, in HIV-1 infected infants and children between the ages of 4 months and 6 years. Patients will commence treatment with saquinavir 50mg/kg bid plus ritonavir 2.5mg/kg or 3.0mg/kg (dependent on body weight), and a background antiretroviral regimen. If drug exposures are found to be dissimilar to those previously seen in older children and adults, or are associated with toxicities, subsequent dose adjustments will be made. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

NCT ID: NCT00623480 Completed - Hemophilia A Clinical Trials

Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment

SPINART
Start date: March 2008
Phase: Phase 3
Study type: Interventional

To evaluate the effect of secondary prophylaxis as compared to episodic treatment on bleeding frequency (number of bleeds per year) and on joint damage.

NCT ID: NCT00623467 Completed - Clinical trials for Central Nervous System Diseases

Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging

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

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.

NCT ID: NCT00623103 Completed - Clinical trials for Parkinson's Disease Dementia

Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)

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

The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.

NCT ID: NCT00622869 Completed - Clinical trials for Liver Transplantation

Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

RAD
Start date: January 2008
Phase: Phase 3
Study type: Interventional

This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.