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NCT ID: NCT01682473 Completed - Neoplasms Clinical Trials

A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

Start date: September 20, 2012
Phase: Phase 1
Study type: Interventional

To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.

NCT ID: NCT01682083 Completed - Melanoma Clinical Trials

Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

COMBI-AD
Start date: January 8, 2013
Phase: Phase 3
Study type: Interventional

This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma were screened for eligibility. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months.

NCT ID: NCT01681550 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Cohort Study of Incretin-based Therapy Combined With Insulin in Type 2 Diabetic Patients for 5 Years

Start date: October 2012
Phase: N/A
Study type: Interventional

The use of dipeptidyl-peptidase 4 (DPP-4) inhibitors and glucagon like peptide 1 (GLP1) analogues for the treatment of diabetic mellitus (DM) type 2 is growing (1,2). Currently, some of these agents have been approved in combination with insulin. The potential for combined use with insulin has garnered increasing attention due to reduce side effects associated with insulin therapy and improve glycemic control. Some investigators reported that GLP-1 analogue combined with insulin reduces HbA1c and weight with low risk of hypoglycemia and high treatment satisfaction (3). However, their duration of treatment was short time with less than a mean of 3.0 years and the alterations of chronic diabetic complications by combination with incretin-based and insulin therapies are not known. We evaluated the long effects of adding incretin-based therapy (DPP-4 inhibitors or GLP-1 analogues) to insulin therapy on glycated hemoglobin (HbA1c) as glycemic control, body mass index (BMI), blood pressure (BP), insulin dosage, frequency of hypoglycemia, and chronic diabetic complications for 5 years-treatments.

NCT ID: NCT01681212 Completed - Melanoma Clinical Trials

Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Advanced Melanoma

Start date: October 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the survival rate after 1 year of treatment with ipilimumab plus dacarbazine in patients with previously untreated Stage III (unresectable) or Stage IV melanoma.

NCT ID: NCT01680159 Completed - Psoriatic Arthritis Clinical Trials

A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis

Start date: July 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650 at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but decreased thereafter.

NCT ID: NCT01679951 Terminated - Clinical trials for Rheumatoid Arthritis

A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate

Start date: October 31, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this dose range finding study is to assess the effectiveness, safety and tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy.

NCT ID: NCT01677624 Completed - Clinical trials for Hypervascular Tumor and Arteriovenous Malformation

A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation

Start date: August 2012
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in Japanese subjects with hypervascular tumor or arteriovenous malformation

NCT ID: NCT01677000 Completed - Clinical trials for Staphylococcus Aureus

Clinical Priority Program-Bone Infection Registry

CPPInfection
Start date: June 2012
Phase:
Study type: Observational

Establish an international registry of over 400 patients with deep infections involving the bone and/or joint from≥20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare researchers. Using a data collection platform that minimizes entry burden, collects most information at the time of surgery, and uses Internet technology to minimize data entry. The registry will include: 1. baseline patient attributes; 2. surgical approach, implants and technology; 3. hospital course; 4. surgeon and institutional characteristics; 5. longitudinal patient outcome, 6. post-procedure complications and revisions, 7. serum/tissue/drainage samples.

NCT ID: NCT01676233 Completed - Clinical trials for Type 1 Diabetes Mellitus

Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus

Start date: September 2012
Phase: Phase 1
Study type: Interventional

Primary Objective: - To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state Secondary Objectives: - To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments; - To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c)); - To compare the occurrence of hypoglycemia between the 2 treatments; - To assess the safety and tolerability of a new formulation of insulin glargine.

NCT ID: NCT01676220 Completed - Clinical trials for Type 2 Diabetes Mellitus

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy

EDITION III
Start date: August 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus Secondary Objectives: To compare a new formulation of insulin glargine and Lantus in terms of: - occurrence of nocturnal hypoglycemia