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NCT ID: NCT01223027 Completed - Clinical trials for Metastatic Renal Cell Carcinoma

Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma

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

This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.

NCT ID: NCT01219959 Completed - Diabetes Clinical Trials

Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients

EDEN
Start date: October 2010
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels. Secondary Objectives: To demonstrate that use of glucose-sparing Peritoneal Dialysis solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life.

NCT ID: NCT01210885 Completed - Clinical trials for Meningococcal Disease

Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents

Start date: December 2010
Phase: Phase 2
Study type: Interventional

The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 years.

NCT ID: NCT01209780 Completed - Seasonal Influenza Clinical Trials

Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age

Start date: September 2010
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and immunogenicity in healthy children and adolescents after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.

NCT ID: NCT01204593 Completed - Clinical trials for Diabetes Mellitus, Type 1

baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus

SUBSTITUTE
Start date: November 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type 1 Diabetes Mellitus (T1DM). Secondary Objectives: To evaluate: - The change of hemoglobin A1c (HbA1c) from baseline to week 12 - The percentage of patients with HbA1c < 7% at week 12 and week 24 - The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and week 24 - The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24 - The incidence of symptomatic hypoglycemias - Adverse events

NCT ID: NCT01202760 Completed - Clinical trials for Rheumatoid Arthritis

A Rheumatoid Arthritis Study in Participants

FLEX O
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis with or without background disease-modifying anti-rheumatic drug (DMARD) therapy. This study is comprised of 2 periods: Period 1 - 24-week blinded treatment Period 2 - 48-week post-treatment follow-up

NCT ID: NCT01200758 Completed - Clinical trials for Non-Hodgkin's Lymphoma

A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma

Start date: February 15, 2011
Phase: Phase 3
Study type: Interventional

This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.

NCT ID: NCT01200160 Completed - Clinical trials for Cardiovascular Diseases

Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America

Start date: February 2010
Phase: N/A
Study type: Observational

Post-Marketing Observational study of Niaspan® tablet in accordance with each country regulations. This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the follow-up of subject's is not prescriptive in nature and is according to the judgment of the physician (investigator in the course of treatment for each patient), within the period of observation of 12 months. This includes an enrollment period of 6 months in which each subject will be observed for approximately 6 months. Examinations, diagnostic measures, findings and observations performed as per usual medical practice during the observation period will be recorded on Case Report Forms (CRFs) by the investigator or site staffs according to the protocol.

NCT ID: NCT01199081 Completed - Atrial Fibrillation Clinical Trials

Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation

ARTEMIS AF LT
Start date: October 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: - Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to different timings of Dronedarone initiation. Secondary Objective: - Explore potential PK interaction between Dronedarone and Amiodarone - Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from randomization up to 60 days after) - To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone safety

NCT ID: NCT01197508 Completed - Clinical trials for Major Depressive Disorder

A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder.

Start date: September 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.