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NCT ID: NCT00263588 Completed - Neoplasms, Breast Clinical Trials

Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

Start date: December 2, 2005
Phase: Phase 2
Study type: Interventional

Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.

NCT ID: NCT00262847 Completed - Clinical trials for Ovarian Endometrioid Adenocarcinoma

Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Start date: September 2005
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.

NCT ID: NCT00262691 Recruiting - Healthy Clinical Trials

Investigation of Genetic Risk of Cardiovascular Disease in Prospective Cohort Study

Start date: May 2005
Phase: N/A
Study type: Observational

Cardiovascular disease is a complex multifactorial and polygenic disorder that is thought to result from an interaction between a person's genetic make up and various environmental factors. Although many studies have revealed that several genetic variants increase the risk of cardiovascular disease, the results of these studies remain controversial. The purpose of this study is to identify polymorphisms that confer susceptibility to cardiovascular disease and to clarify the adequacy of reported susceptibility gene polymorphisms. To complete this purpose, we will prospectively study over 5,000 local residents in whom relationship between these polymorphisms and occurrence of cardiovascular disease over 5 years.

NCT ID: NCT00262600 Completed - Stroke Clinical Trials

Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate

Start date: December 2005
Phase: Phase 3
Study type: Interventional

The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.

NCT ID: NCT00261417 Terminated - Type 2 Diabetes Clinical Trials

Dose Response Study in Japanese Patients

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

This is a 12-week study to determine the effect on glucose and lipids, safety, and tolerability of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) compared with placebo in patients with type 2 diabetes. Improvement in dyslipidemia will be evaluated. The study comprises a 2-week screening period, 4-week placebo run-in, a 12-week randomized, double blind, parallel group, multi-center, placebo-controlled treatment period, and a 3-week follow-up.

NCT ID: NCT00259077 Completed - Clinical trials for Non-erosive Reflux Disease

Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population

Start date: October 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to study safety and efficacy of omeprazole standard treatment in a Japanese non-erosive reflux disease population.

NCT ID: NCT00259051 Completed - Clinical trials for Non-erosive Reflux Disease

A Study to Investigate the Pharmacodynamic Effect After Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population

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

The purpose of this study is to investigate the pharmacodynamic effect of omeprazole n a Japanese non-erosive reflux disease population

NCT ID: NCT00258011 Completed - Clinical trials for Mucopolysaccharidosis I

Study of Aldurazyme® Replacement Therapy in Patients With Mucopolysaccharidosis I (MPS I) Disease

Start date: December 2005
Phase: Phase 3
Study type: Interventional

This is a multi-center, open label, study conducted to evaluate the safety of laronidase administered by intravenous drip infusion in Japanese patients with MPS I disease. Following baseline evaluation, patients will receive weekly infusions of JC0498 at an intravenous dose of 100 units/kg. Patient safety will be monitored continuously throughout the trial. In addition, the effects of JC0498 treatment in this patient population will be assessed by periodically evaluating aspects of MPS I disease in patients at scheduled intervals over the duration of the trial. Since patients may be eligible for the trial if they have received JC0498, a portion of the data may be captured retrospectively and recorded onto the case report forms (CRFs). This study represents the first good clinical practice (GCP) effort to characterize MPS I in the Japanese population and evaluate the effects of JC0498 on disease manifestations.

NCT ID: NCT00257881 Terminated - Neoplasms Clinical Trials

Study Evaluating Intravenous CMD-193 in Subjects With Advanced Malignant Solid Tumors

Start date: November 2005
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of CMD-193 administered intravenously (IV) to subjects with advanced malignant tumors. The secondary purpose is to obtain preliminary information on the pharmacokinetics and antitumor activity of IV CMD-193.

NCT ID: NCT00255255 Completed - Asthma Clinical Trials

Safety & Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma

Start date: November 2005
Phase: Phase 3
Study type: Interventional

This study is to confirm the safety of Symbicort® Turbuhaler® 160/4.5 µg 1, 2 or 4 inhalation b.i.d. over a 52 week treatment period in asthmatic patients who are being treated with IGCS and long acting β2-agonist (LABA) and/or other anti-asthmatic drugs.