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NCT ID: NCT01205438 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

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

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.

NCT ID: NCT01204749 Completed - Ovarian Cancer Clinical Trials

TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

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

The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

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: NCT01203111 Completed - Clinical trials for Diabetes Mellitus, Type 2

Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs

CHANGING
Start date: December 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week 24 (visit 10). Secondary Objectives: 1. Percentage of patients with HbA1c < 7% at week 24. 2. Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event at week 24. 3. Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week 0, week 12 and week 24. 4. Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose / kg (U/kg) will be calculated at week 24. 5. Systolic and diastolic blood pressure, heart rate, weight change will be measured at week 0, week 12 and week 24. 6. Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe) will be evaluated during the treatment period. 7-Adverse events.

NCT ID: NCT01202773 Terminated - Clinical trials for Rheumatoid Arthritis

A Study in Participants With Rheumatoid Arthritis

FLEX V
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 in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors. This study is comprised of 2 periods: Period 1: 24-week blinded treatment Period 2: 48-week post-treatment follow-up

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: NCT01200394 Completed - Clinical trials for Diabetic Nephropathies

A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy

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

PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.

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: NCT01199120 Completed - Malnourishment Clinical Trials

Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition

Start date: March 2009
Phase: Phase 2
Study type: Interventional

Adequate nutrition is one of the critical biological processes to learning and cognitive development of children. And is understandable that malnourishment affect these processes. Moreover, in recent decades it has been investigated the beneficial effects of Omega-3 in cognitive development and academic performance. However, studies have been limited. Therefore is of interest to know the effects that has supplement with Omega-3 for children 8-12 years with malnutrition in a randomized, blind, placebo-controlled.