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NCT ID: NCT01297491 Completed - Clinical trials for Non-small Cell Lung Cancer

Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer

BASALT-1
Start date: May 2011
Phase: Phase 2
Study type: Interventional

The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.

NCT ID: NCT01294761 Completed - HIV Infections Clinical Trials

Comparing Continuing Tenofovir, Emtricitabine (or Lamivudine) Plus Lopinavir and Switching to Raltegravir Plus Darunavir

SPARE
Start date: February 2011
Phase: N/A
Study type: Interventional

The main objective of this clinical trial in randomizing HIV infected patients under good HIV control with tenofovir (TDF), emtricitabine (or lamivudine) plus lopinavir/ritonavir (LPV/r) into switching the regimen to raltegravir (RAL) with darunavir/ritonavir (DRV/r) or continuing the ongoing regimen to compare these two groups' estimated glomerular filtration rate (eGFR) is to investigate whether anti-HIV treatment that does not contain TDF or other reverse-transcriptase inhibitors (NTRI sparing regimen) can be protective of patients' renal functions and has the same virological efficacy in comparison with a standard treatment with TDF, or not.

NCT ID: NCT01294462 Completed - Clinical trials for Acute Coronary Syndrome

Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)

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

The purpose of the study is to assess the efficacy (prevention of vascular events) and safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned percutaneous coronary intervention (PCI).

NCT ID: NCT01294436 Completed - Type2 Diabetes Clinical Trials

Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus

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

This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.

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.