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NCT ID: NCT01435616 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study in Patients With Type 2 Diabetes Mellitus

IMAGINE 2
Start date: November 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is: - To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. - To compare the rate of night time low blood sugar episodes on LY2605541 with insulin glargine during 52 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 52 weeks of treatment. - To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine after 52 weeks of treatment

NCT ID: NCT01435343 Completed - Clinical trials for Acute Myeloblastic Leukemia

Treatment of Relapsed or Refractory Acute Myeloblastic Leukemia

Start date: July 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Second-line induction therapy with fludarabine, idarubicin, cytarabine,Granulocyte colony-stimulating factor (G-CSF) and plerixafor, in patients with relapsed or refractory Acute Myeloblastic Leukemia (AML) aged 65 or younger.

NCT ID: NCT01434108 Completed - Cirrhosis Clinical Trials

Effects of the Administration of Ornithine Phenylacetate in Patients With Cirrhosis and Upper Gastrointestinal Bleeding

Start date: October 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The main objective is to evaluate the effectiveness of the experimental drug to reduce plasma ammonia concentration at a dose that is safe and well tolerated. Ammonia usually rises significantly in the hours after gastrointestinal bleeding in patients with cirrhosis of the liver. This increase in the concentration of ammonia facilitates the development of hepatic encephalopathy. The study will be divided in two parts: Part A: Open-label, dose-escalating, single cohort study. The goal of this phase is to confirm the tolerance and safety of the dose of OP that is being proposed for the study according to the results of phase I and phase II studies in healthy subjects and stable outpatients with cirrhosis. Part B: Multi-center (2 University Hospitals), double-blind, randomized, parallel-group trial. Assignment of treatment will be done according to a list (one at each study site) of random numbers in blocks that will be concealed until the end of the study. The control group will be assigned to placebo on a 1:1 ratio. The placebo and treatment will be masked.

NCT ID: NCT01433926 Completed - Clinical trials for HER-2 Positive Breast Cancer

Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete, Partial Remission or Stabilization of Disease During More Than 3 Years

LongHer
Start date: September 2009
Phase: N/A
Study type: Observational

Main objective: To analyze the clinical and biological characteristics of patients with disseminated breast cancer HER2 + treated with trastuzumab that have achieved a complete remission, partial or stable disease for a period exceeding 3 years. In addition, there will be a sub-genetic analysis of patients in whom there is availability a sample of primary tumor preserved in paraffin. This sub-analysis will not interfere with routine clinical practice, as the tumor samples based on which will be held on genetic profile, have been preserved in paraffin was extracted from the primary tumor to the patient.

NCT ID: NCT01433497 Completed - Clinical trials for Multiple Sclerosis, Secondary Progressive

Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis

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

The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis.

NCT ID: NCT01433042 Completed - Small/Large Bowel Clinical Trials

PillCam SB3 Capsule- Feasibility Study

Start date: August 2011
Phase: N/A
Study type: Interventional

Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality, and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps, which will create more images for evaluation, and therefore should improve diagnostic accuracy. Proposed Design: to enroll up to 230 patients with symptoms suggesting the presence of small bowel disease. Preparation for procedure will include 12 hours fasting prior to the capsule ingestion Patients will undergo a standard capsule endoscopy. Patients will be allowed to drink clear liquids 2 hours post ingestion, and eat 4 hours post ingestion. Diagnostic yield of the SB3 will be calculated The Physician's subjective assessment of capsule performance will be captured

NCT ID: NCT01432379 Completed - Migraine Disorders Clinical Trials

BOTOX® Prophylaxis in Patients With Chronic Migraine

Start date: September 9, 2011
Phase:
Study type: Observational

This is a post authorization observational study to monitor the utilization practices and describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine.

NCT ID: NCT01432236 Completed - Fibromyalgia Clinical Trials

A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

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

The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.

NCT ID: NCT01431716 Completed - Clinical trials for Pulmonary Arterial Hypertension

Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension

EPITOME-2
Start date: March 2011
Phase: Phase 3
Study type: Interventional

This study is investigating the effect of switching from Flolan® to Epoprostenol for Injection (EFI/ACT-385781A) in pulmonary arterial hypertension patients currently treated with Flolan®. For this purpose patients being treated for at least 12 months with Flolan® will be switched from Flolan® to EFI/ACT-385781A and followed-up for 90 days. During these 90 days safety and tolerability of EFI/ACT-385781A will closely be monitored in all treated patients. This 90 follow-up will provide clinical evidence on the safety, tolerability, efficacy and treatment satisfaction of switching from Flolan® to EFI/ACT-385781A in patients with pulmonary arterial hypertension.

NCT ID: NCT01431287 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

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

The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.