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NCT ID: NCT01526057 Completed - Clinical trials for Rheumatoid Arthritis

A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)

REFLECTIONS
Start date: March 20, 2012
Phase: Phase 2
Study type: Interventional

In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs will be assessed by sampling the levels of drug in the blood, blood cell counts, and by comparing these levels among the different treatments. Safety, tolerability and immunologic response also will be evaluated throughout.

NCT ID: NCT01524783 Completed - Clinical trials for Neuroendocrine Tumors

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)

RADIANT-4
Start date: March 30, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the antitumor activity of everolimus plus best supportive care versus placebo plus best supportive care in patients with progressive nonfunctional neuroendocrine tumor (NET) of gastrointestinal (GI) or lung origin without a history of, or current symptoms of carcinoid syndrome.

NCT ID: NCT01521754 Completed - Refractory Epilepsy Clinical Trials

Product Surveillance Registry- Deep Brain Stimulation for Epilepsy

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Start date: March 6, 2012
Phase:
Study type: Observational

The purpose of this observational registry is to evaluate the long-term effectiveness, safety and performance of market-released Medtronic Neuromodulation products for Deep Brain Stimulation (DBS) for the treatment of refractory epilepsy. In addition, healthcare resource use and patient reported outcomes, such as health related quality of life will be assessed.

NCT ID: NCT01520909 Completed - Clinical trials for Idiopathic Thrombocytopenic Purpura

Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.

PETIT2
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag.

NCT ID: NCT01519960 Completed - Clinical trials for Hepatitis B, Chronic

A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

Start date: July 11, 2012
Phase: Phase 3
Study type: Interventional

This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment with Pegasys. Children in the untreated control Group B who have not experienced seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of Pegasys treatment. This offer will be available for 1 year following 48 weeks from randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period.

NCT ID: NCT01519700 Completed - Breast Cancer Clinical Trials

Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim

PIONEER
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

NCT ID: NCT01519648 Completed - Clinical trials for Invasive Fungal Infections

A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation

Start date: January 2012
Phase: N/A
Study type: Observational

Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.

NCT ID: NCT01517412 Completed - Clinical trials for Type 2 Diabetes Mellitus

Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

Start date: February 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: - To compare the two treatment regimens in terms of change of HbA1c from baseline to endpoint (week 24) Secondary Objective: - To assess the effect of the 2 lixisenatide regimens on: - The percentage of patients who reached the target of HbA1c < 7% or ≤ 6.5% at week 24 - Fasting Plasma Glucose (FPG) - 7-point Self-Monitored Plasma Glucose (SMPG) profiles - Body weight - To assess the safety and tolerability of the 2 lixisenatide regimens

NCT ID: NCT01516736 Completed - Breast Cancer Clinical Trials

Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim

PROTECT2
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy of LA-EP2006 compared to Peg-Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

NCT ID: NCT01515423 Completed - Schizophrenia Clinical Trials

Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

Start date: May 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.