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NCT ID: NCT00479336 Completed - Cirrhosis Clinical Trials

A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema

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

To investigate the dose response for changes from baseline in body weight as a primary endpoint and to investigate improvement in ascites, abdominal circumference, lower-limb edema, and pleural effusion as secondary endpoints in seven-day repeated oral administration of OPC-41061 at 7.5, 15, and 30 mg/day or placebo in cirrhosis patients with ascites despite taking conventional diuretics.

NCT ID: NCT00479076 Completed - Neoplasms Clinical Trials

A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients

Start date: March 2007
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the recommended phase II dose of AVE0005 in combination with S-1 in Japanese cancer patients. The secondary objectives of this study are to assess the safety profile of AVE0005, to determine the pharmacokinetics of AVE0005, to make a preliminary assessment of antitumor effects.

NCT ID: NCT00477464 Completed - Clinical trials for Metastatic Breast Cancer

Lapatinib in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer

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

This study is to evaluate the safety and efficacy of lapatinib taken together with capecitabine in Japanese patients. The study will proceed in two phases; the first phase(Part1) will lead to an evaluation of the mainly tolerability as well as PK parameters. If there are no major safety concerns in Part 1, the study will move into the second phase (Part 2) to further evaluate the safety and clinical activity.

NCT ID: NCT00476437 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Effect of Biphasic Insulin Aspart 50 in Patients With Type 2 Diabetes Mellitus.

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

This trial is conducted in Japan. The purpose of this trial is to investigate the safety and the effect of biphasic insulin aspart 50 compared to biphasic human insulin 50 in patients with type 2 diabetes mellitus.

NCT ID: NCT00475319 Completed - Dry Eye Syndromes Clinical Trials

Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

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

The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye patients

NCT ID: NCT00471497 Completed - Clinical trials for Myelogenous Leukemia, Chronic

A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

ENESTnd
Start date: July 31, 2007
Phase: Phase 3
Study type: Interventional

In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.

NCT ID: NCT00471146 Completed - Clinical trials for Carcinoma, Pancreatic Ductal

Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

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

The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.

NCT ID: NCT00469131 Completed - Hepatitis C Clinical Trials

Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparative Study Between Tacrolimus + MMF and Tacrolimus + Steroid

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

The aim of this study is to compare immunosuppression protocol of tacrolimus + MMF with that of tacrolimus + steroid for preventing recurrence of hepatitis C after living donor liver transplantation.

NCT ID: NCT00467012 Completed - Clinical trials for Metastatic Breast Cancer

Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer

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

To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.

NCT ID: NCT00463151 Completed - Colitis, Ulcerative Clinical Trials

An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

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

The purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).