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NCT ID: NCT01481779 Completed - Clinical trials for Diabetes Mellitus, Type 1

A Study in Participants With Type 1 Diabetes Mellitus

IMAGINE 1
Start date: January 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is: - To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment. - To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 weeks of treatment. - To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 78 weeks of treatment. - To compare the rate of hypoglycemia episodes on LY2605541 with insulin glargine during 78 weeks of treatment.

NCT ID: NCT01480284 Completed - Clinical trials for Hepatitis B, Chronic

Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue

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

The purpose of this study is to evaluate the efficacy and safety of GSK548470 administered once daily at a dose level of 300 mg to Japanese patients with compensated chronic hepatitis B untreated with any nucleic acid analogue. In efficacy, the non-inferiority of GSK548470 to ETV will be verified using the antiviral effect as the index.

NCT ID: NCT01480245 Terminated - Clinical trials for Muscular Dystrophies

Open Label Study of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

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

The purpose of this study is to explore long-term safety, tolerability and efficacy of GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.

NCT ID: NCT01480180 Completed - Clinical trials for Congenital Bleeding Disorder

Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A

pathfinderâ„¢2
Start date: January 30, 2012
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.

NCT ID: NCT01479387 Completed - Clinical trials for Non-Hodgkin's Lymphoma (NHL)

Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan

ZEVALIN-SDUI
Start date: August 2008
Phase: N/A
Study type: Observational

This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess biodistribution of the Zevalin. When the imaging shows no altered distribution, Y-90 Zevalin is injected to the patient for the actual treatment. The objective of this study is to assess appropriateness and necessity of revision of the standardized criteria for image interpretation of In-111 Zevalin by comparing assessment by the investigator and the members of the committee for image interpretation of In-111 Zevalin. A total 40 patients will be recruited.

NCT ID: NCT01478633 Completed - Alzheimer's Disease Clinical Trials

Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil

Start date: September 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of galantamine in patients who failed to benefit from donepezil (patients switching from donepezil). In clinical practice, it is expected that galantamine will be used in patients switching from donepezil due to the insufficient efficacy of donepezil.

NCT ID: NCT01477983 Completed - Atrial Fibrillation Clinical Trials

Kansai Plus Atrial Fibrillation Trial

KPAF
Start date: November 2011
Phase: Phase 4
Study type: Interventional

This is a 2x2 factorial randomized controlled trial (KPAF Trial), evaluating two different pharmacological approaches to improve long-term outcome of catheter ablation for atrial fibrillation (AF). The study is composed of UNmasking Dormant Electrical Reconduction by Adenosine TriPhosphate (UNDER-ATP) Trial and Efficacy of Antiarrhythmic Drugs Short-Term Use after Catheter Ablation for Atrial Fibrillation (EAST-AF) Trial. Patients with paroxysmal or persistent AF will be randomized to ATP guide ablation or control group in a 1:1 ratio before the procedure (UNDER-ATP Trial). Excluding those with severe procedural complications or substantial bradycardia identified first after ablation for persistent AF, patients will be randomized in a 1:1 ratio to antiarrhythmic-drug (AAD) or control group after the procedure (EAST-AF Trial).

NCT ID: NCT01477359 Recruiting - Cardiac Sarcoidosis Clinical Trials

Cardiac Sarcoidosis Multi-Center Prospective Cohort

CHASM-CS
Start date: August 2012
Phase:
Study type: Observational

Recent data has shown that sarcoidosis, presenting initially with cardiac manifestations (CS) of either conduction system disease or cardiomyopathy and sustained VT, is not uncommon. A Canadian physician survey found that most physicians do not investigate for CS as a possibility in these situations. Thus many patients with clinically important CS are going un-diagnosed. A study from Finland showed that missing the diagnosis of CS in these patients' leads to significant mortality and morbidity. There are no published clinical consensus guidelines on treatment of CS. Corticosteroid therapy is advocated by most experts. This is based on very modest data from small retrospective observational studies using variable definitions of clinical response. The effect of corticosteroid treatment on the clinical course of CS has not been studied in prospective studies and will be one of the aims of this project. Recent physician surveys regarding CS, in Canada and the US, found that current clinical practice varies widely. The 2008 American College of Cardiology/American Heart Association/Heart Rhythm society guidelines recommend implantation of a defibrillator (Class IIa recommendation) to prevent sudden cardiac death. The most recent Canadian device therapy guidelines do not mention CS. A multi-center collaborative approach to study CS is greatly needed." The investigators propose exactly that i.e. a multi-center prospective cohort to start to answer clinical questions. The investigators have formed the CANADIAN CARDIAC SARCOIDOSIS RESEARCH GROUP. The group includes respirologists with an interest in sarcoidosis, cardiac electrophysiologists, cardiac imaging specialists with extensive experience in imaging of sarcoidosis and biostatisticians. The research will be in two phases; a registry of current diagnostic approaches, treatment and prognosis, and a randomized clinical trial of the effect of corticosteroid treatment on the clinical course of cardiac sarcoidosis.

NCT ID: NCT01476787 Completed - Follicular Lymphoma Clinical Trials

Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma

RELEVANCE
Start date: December 29, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide and rituximab in controlling the Follicular Lymphoma disease and also increase the length of response compared to the available standard combination chemotherapy treatment for Follicular Lymphoma.

NCT ID: NCT01475851 Completed - Clinical trials for Hepatitis B, Chronic

Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs

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

The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response to other drugs.