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NCT ID: NCT02057250 Completed - Clinical trials for Rheumatoid Arthritis

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

SARIL-RA-EASY
Start date: March 2014
Phase: Phase 3
Study type: Interventional

Primary Objective: To collect real-use data of the sarilumab auto-injector used by rheumatoid arthritis (RA) patients. Secondary Objective: To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).

NCT ID: NCT02056015 Completed - Clinical trials for Imaging of Solid Gastrointestinal Tumors

A Phase I Study of MLN6907 in Patients With Metastatic Colorectal

Start date: June 2015
Phase: Phase 1
Study type: Interventional

This study is a first-in-human (FIH), single-dose, open-label, phase 1 study designed to assess the safety, pharmacokinetics (PK), distribution, and radiation dosimetry of [68Ga]MLN6907 after a single intravenous (IV) administration. Patients with Metastatic Colorectal Carcinoma who are scheduled for resection of liver metastases as part of their treatment plan will be eligible for enrollment.

NCT ID: NCT02055352 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD

COMBINE
Start date: May 30, 2014
Phase: Phase 4
Study type: Interventional

To demonstrate the free combination of budesonide and indacaterol is as efficacious as fluticasone and salmeterol in patients with COPD

NCT ID: NCT02055118 Completed - Hunter Syndrome Clinical Trials

Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment

AIM-IT
Start date: March 24, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter syndrome and cognitive impairment who have previously received and tolerated a minimum of 4 months of therapy with Elaprase.

NCT ID: NCT02054897 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes

SUSTAIN™1
Start date: February 3, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes. (SUSTAIN™ 1-Monotherapy).

NCT ID: NCT02053610 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)

Start date: December 31, 2009
Phase: Phase 3
Study type: Interventional

This open-label, randomized, 3-arm study will evaluate the efficacy and safety of (obinutuzumab) RO5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

NCT ID: NCT02052310 Completed - Clinical trials for Anemia in Incident Dialysis Patients

Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants

Himalayas
Start date: February 11, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.

NCT ID: NCT02052141 Completed - Clinical trials for Hereditary Angioedema (HAE)

Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema

Start date: March 20, 2014
Phase: Phase 3
Study type: Interventional

Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE). Secondary Objectives - To assess the safety and tolerability, characterize the pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.

NCT ID: NCT02051842 Recruiting - NAFLD Clinical Trials

Effect of Metadoxine on Oxidative Stress in Non-alcoholic Hepatic Steatosis

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Oxidative stress is produced by imbalance between reactive oxygen species and antioxidant systems. This state is frequently associated with chronic diseases like obesity, insulin resistance, metabolic syndrome and hepatic steatosis. In the liver, the oxidative stress may trigger the progression of fatty liver disease, from triglyceride accumulation to inflammation, cirrhosis and hepatocellular carcinoma. Thus, the attenuation of oxidative stress, could be an important therapeutic target to lessen the severity of the disease. Until now, there is not a medical treatment to cure non-alcoholic fatty liver disease, but therapies aimed at reducing oxidative stress have been proposed. Metadoxine, an ionic complex of pyridoxine-pyrrolidone molecule, acts as a synthetic antioxidant, forming traps that can reduce free radicals; likewise, metadoxine has a proven capacity to reduce fat liver in alcoholic hepatitis. Finally, in fact that alcoholic and non-alcoholic liver diseases share molecular mechanisms in the generation of oxidative stress, the investigators propose metadoxine as a posssible modifier of the oxidative stress in non-alcoholic liver disease, prediabetic patients.

NCT ID: NCT02049411 Completed - Clinical trials for Postoperative Cognitive Dysfunction

Ketamine and Changes of the Short Portable Mental Status Questionnaire

SPMSQ-E
Start date: June 2013
Phase: Phase 2
Study type: Interventional

- Cognitive changes are related to aging, affecting the performance of older patients in the solution of problems and the execution of tasks. This phenomenon has been observed as a decline of neurophysiological domains, especially memory, and the velocity of thought. - Anesthesia and surgery performed contributes to its development then, is named post-operative cognitive dysfunction (POCD). The incidence varies due to conditions of: 1. Anesthesia and surgery. 2. The time elapsed after surgery. 3. The population studied, and the type of cognitive test employed. - The aim of this study is to evaluate the changes around the Short Portable Mental Status Questionnaire (SPMSQ-E) after ketamine administration on ophthalmic surgery on the common conditions of geriatric patients, —comorbid and settings as minor surgery—.