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NCT ID: NCT01294423 Completed - Type 2 Diabetes Clinical Trials

Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus

Start date: February 2011
Phase: Phase 3
Study type: Interventional

This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.

NCT ID: NCT01294215 Completed - Hypertension Clinical Trials

High Dose BAYA1040_Nifedipine: a Long Term Combination Study

Start date: February 2011
Phase: Phase 3
Study type: Interventional

This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.

NCT ID: NCT01294085 Completed - Clinical trials for Biliary Tract Cancer

Case Series Study of Biliary Tract Cancer Patients in Japan

Start date: November 2010
Phase: N/A
Study type: Observational

To assess the difference of prognosis between unresectable and recurrent biliary tract cancer and evaluate prognostic factors.

NCT ID: NCT01293630 Completed - Clinical trials for Advanced Solid Tumors

A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors

Start date: January 2011
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to determine the maximum tolerated dose (MTD) based on the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients with advanced solid tumors. Secondary Objectives: - To assess the overall safety profiles of the combination therapy - To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, paclitaxel, and carboplatin when used in combination - To document the objective tumor response

NCT ID: NCT01293383 Completed - Healthy Clinical Trials

A Study Evaluating the Safety of LEO 90105 and Its Vehicle, After Multiple Administration on Intact Skin of Healthy Japanese Male Subjects

Start date: March 2011
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to to investigate the safety of LEO 90105 compared with its vehicle after multiple administration (twice daily, 5 days) in healthy Japanese male subjects.

NCT ID: NCT01293357 Completed - Healthy Clinical Trials

A Study Evaluating Skin Irritation, Phototoxicity and Safety After Administration of LEO 90105 on Intact Skin of Healthy Japanese Male Subjects

Start date: December 2010
Phase: Phase 1
Study type: Interventional

The objective of the trial is to investigate skin irritation, phototoxicity and safety of LEO 90105 and its components by patchtest (48 hours closed patch test and photo patch test) in healthy Japanese male subjects.

NCT ID: NCT01292928 Active, not recruiting - Clinical trials for Atherosclerosis of Native Arteries of the Extremities, Unspecified

SuperNOVA Clinical Stenting Trial

Start date: April 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this clinical study is to determine whether the Innova Stent System shows acceptable performance in long-term (12-month) safety rates and vessel patency when treating femoropopliteal lesions.

NCT ID: NCT01292837 Completed - Epilepsy Clinical Trials

A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures

Start date: February 2011
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).

NCT ID: NCT01292239 Completed - Clinical trials for Hepatitis C, Chronic

A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients

Start date: February 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of TMC435 compared with placebo in combination with peginterferon alfa-2a (pegIFN alfa-2a) and ribavirin in treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection in Japan.

NCT ID: NCT01291615 Completed - Clinical trials for Biliary Tract Cancer

Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer

Start date: December 2010
Phase: Phase 1
Study type: Interventional

To decide maximum tolerated dose and/or recommended dose of Gemcitabine or S-1 adjuvant therapy after hemihepatectomy