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NCT ID: NCT00971542 Completed - Pandemic Influenza Clinical Trials

Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine (Egg-Derived) in Healthy Subjects From 6 Months to 17 Years of Age

Start date: September 2009
Phase: Phase 3
Study type: Interventional

The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and adolescents. A booster dose will be administered 12 months after the first vaccination.

NCT ID: NCT00971503 Withdrawn - Clinical trials for Type 1 Diabetes Mellitus

Safety and Efficacy of Arterial Delivery of Autologous Bone Marrow Cells in the Treatment of Insulin-Dependent Diabetes

Start date: February 2011
Phase: Phase 2
Study type: Interventional

Diabetes mellitus is a long-term multi-organ disease with severe implications that constitute a major health problem worldwide. Type 1 diabetes is an autoimmune disorder in which the body's own immune system attacks and destroys the cells that make insulin. Exogenous administration of insulin is the primary method of controlling type 1 diabetes by regulating blood glucose levels, but this treatment does not reverse nor prevent disease progression. Our hypothesis is that when implanting stimulated total bone marrow by arterial injection directly into the pancreas, we will achieve functional recovery of insulin-producing cells. This study will include patients with chronic type 1 diabetes and absence of lesions in target organs. We will follow the evolution of patients receiving autologous total bone marrow implantation by selective catheterization and compare to a non-treatment control group. All subjects will continue to use insulin therapy as needed to maintain the best possible glucose control. The objective is to achieve a significant increase in C-peptide levels indicating a regeneration of the beta islet cells with a decrease in exogenous insulin usage in at least 70% of the patients. This study is a follow-up to our initial study in which 22 patients received autologous total bone marrow. The initial study was 100% safe but additional studies like the one described above are needed to show efficacy.

NCT ID: NCT00968708 Completed - Clinical trials for Diabetes Mellitus, Type 2

Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome

EXAMINE
Start date: September 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.

NCT ID: NCT00967616 Completed - Colorectal Cancer Clinical Trials

Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy

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

This phase 2, randomized, active-controlled, open-label, parallel group, multicenter study will be conducted at up to 18 study centers in the US, Central America, and South America. Adult subjects with metastatic colorectal cancer (CRC) who failed first-line chemotherapy will participate in the study, which will be conducted on an outpatient basis. It is anticipated that 100 subjects will be enrolled to obtain approximately 90 evaluable subjects.

NCT ID: NCT00966875 Completed - Clinical trials for Rheumatoid Arthritis

A Study in Patients With Rheumatoid Arthritis

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

The primary purpose of the study is to help answer the following research questions, and not to provide treatment for Rheumatoid Arthritis (RA): - The safety of LY2439821 and any side effects that might be associated with it. - Whether LY2439821 can help patients with active RA. - How much LY2439821 should be given to patients.

NCT ID: NCT00958776 Terminated - Headache Clinical Trials

A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza

Start date: November 2009
Phase: Phase 3
Study type: Interventional

A Phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of peramivir administered intravenously in addition to standard of care compared to standard of care alone in adults and adolescents who are hospitalized due to serious influenza.

NCT ID: NCT00956644 Completed - Hypertension Clinical Trials

Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy

I-COMBINE
Start date: July 2009
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate that the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 150/5 mg is superior to that of amlodipine 5 mg monotherapy in lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM) after 5 weeks of treatment (W5) Secondary Objective: - To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 150/5 mg with that of amlodipine 5 mg monotherapy after 5 weeks of treatment (W5) - To compare the antihypertensive efficacy of the fixed combination therapy irbesartan/amlodipine 150/10 mg with that of amlodipine 10 mg monotherapy at the end of treatment (W10) - To examine in each treatment group the change from week 5 to week 10 in SBP and diastolic blood pressure (DBP) assessed by HBPM and by office blood pressure measurement (OBPM) - To determine the incidence and severity of adverse events

NCT ID: NCT00954590 Terminated - Clinical trials for Moderate to Severe Alzheimer

A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease

CONTACT
Start date: October 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease.

NCT ID: NCT00949910 Completed - Clinical trials for Non-Small Cell Lung Cancer

An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

Start date: November 2004
Phase: Phase 4
Study type: Interventional

This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.

NCT ID: NCT00949650 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

Start date: August 14, 2009
Phase: Phase 3
Study type: Interventional

This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.