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NCT ID: NCT01924533 Completed - Gastric Cancer Clinical Trials

Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.

Start date: September 3, 2013
Phase: Phase 3
Study type: Interventional

This study is a phase III, multi-centre study of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy. Patients will be from China, Japan , Korea and Taiwan.

NCT ID: NCT01924520 Completed - Clinical trials for Major Depressive Disorder

Oral Multiple-dose Study in Patients With Major Depressive Disorder

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

A study was to evaluate the safety and plasma concentration changes of quetiapine after repeated administration of FK949E (extended-release formulation of quetiapine) in patients with major depressive disorder (MDD).

NCT ID: NCT01923168 Completed - Breast Cancer Clinical Trials

Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women

Start date: March 11, 2014
Phase: Phase 2
Study type: Interventional

The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer.

NCT ID: NCT01920711 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction

PARAGON-HF
Start date: July 18, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.

NCT ID: NCT01920477 Terminated - Pemphigus Vulgaris Clinical Trials

Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris

Start date: August 13, 2013
Phase: Phase 3
Study type: Interventional

Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening autoimmune disorder that is characterized by mucocutaneous blisters. Ofatumumab is a novel monoclonal antibody (mAb) that specifically binds to the human CD20 antigen, which is expressed only in B lymphocytes. The purpose of this study was to evaluate the efficacy, tolerability, and safety of ofatumumab injection for subcutaneous use (ofatumumab SC) 20 milligrams (mg) administered once in every 4 weeks, (with an additional 20 mg loading dose [i.e. 40 mg total] at both Week 0 and Week 4) in subjects with PV. It was anticipated that with sustained B-cell depletion in the presence of ofatumumab SC, and the resultant reduction of pathogenic anti Dsg (desmoglein) autoantibodies in PV, that clinical remission of the disease would result.

NCT ID: NCT01919398 Completed - Neoplasm Metastasis Clinical Trials

A Study of LY2940680 in Japanese Participants With Advanced Cancers

Start date: August 2013
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to assess the safety and tolerability of LY2940680 up to the global recommended dose in Japanese participants with advanced solid cancers.

NCT ID: NCT01919047 Completed - Overactive Bladder Clinical Trials

Drug Use-Results Survey of Betanis Tablets in Japan

Start date: April 2012
Phase: N/A
Study type: Observational

This study is to determine the following information. 1. The occurrence of adverse drug reactions in clinical settings. 2. Factors potentially impacting safety, effectiveness, and other aspects.

NCT ID: NCT01919008 Completed - Clinical trials for Major Depressive Disorder

Comparison of Plasma Concentration Changes Between Two Types of Tablets of FK949E Administration to Patients With Major Depressive Disorder

Start date: March 26, 2012
Phase: Phase 1
Study type: Interventional

This study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose tablets in non-elderly patients with major depressive disorder. The safety of FK949E in the population was also evaluated.

NCT ID: NCT01918813 Completed - Clinical trials for Inflammatory Bowel Disease

Risk of Methicillin-resistant S.Aureus (MRSA) Infections in MRSA Carrier Under Introduction of Rapid MRSA Screening

Start date: November 2009
Phase: N/A
Study type: Interventional

This study was designed to evaluate the effect of a targeted preoperative Methicillin-resistant Staphylococcus aureus (MRSA) detection by polymerase chain reaction (PCR) on either endogenous or exogenous postoperative MRSA infections in a high risk population undergoing gastroenterological surgery. The primary endpoint was to investigate whether the potentially high incidence of MRSA infections in patients with MRSA nasal colonization before surgery can be prevented with a PCR-based strategy. The second endpoint was to investigate the impact of acquisition of MRSA colonization after surgery on the occurrence of MRSA infections. Investigators hypothesize that postoperative MRSA infection is prevented by a targeted screening strategy in preoperative MRSA carrier, and there is limited effect in patients with postoperative MRSA acquisition.

NCT ID: NCT01918384 Active, not recruiting - Clinical trials for Muscular Dystrophy, Duchenne

Phase II Study of NPC-14 (Arbekacin Sulfate) to Explore Safety, Tolerability, and Efficacy in Duchenne Muscular Dystrophy

NORTH POLE DMD
Start date: August 2013
Phase: Phase 2
Study type: Interventional

Duchenne Muscular Dystrophy (DMD) is inherited neuromuscular disorders due to mutation in the gene that encodes critical muscle protein called dystrophin. Currently, there is no effective treatment option for the disease. A pharmacological approach by promoting mRNA translation regardless of the presence of premature stop codons by nonsense mutation, called the readthrough strategy, has been developing recently for DMD with nonsense mutation. NPC-14 is a candidate compound for the readthrough strategy, since effective readthrough activities were demonstrated in nonclinical studies. This study is a phase II study designed to assess safety, tolerability, and efficacy of NPC-14 in ambulant DMD patients with nonsense mutation that were confirmed by whole genome analysis. These goals will be accomplished by monitoring adverse events by physical examination, cardiac, pulmonary, auditory, balance, and laboratory tests as safety endpoints, and dystrophin expression in muscle biopsy as primary efficacy endpoint, muscle function (NSAA, timed test, muscle strength (QMT, MMT) , dairy activities by lifecorder), and biomarkers as secondary efficacy endpoints. The study is a randomized, double blind, placebo-controlled study in 21 DMD patients. After screening, eligible patients are allocated dynamically to weekly NPC-14 or a placebo (saline) in a 2:1 ratio and will receive study drugs for 36 weeks.