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NCT ID: NCT01034163 Completed - Hodgkin's Lymphoma Clinical Trials

A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma

PATH
Start date: June 2010
Phase: Phase 3
Study type: Interventional

The purpose of this phase III study is to evaluate the efficacy of orally-administered panobinostat in reducing the risk of relapse in patients with classical Hodgkin's Lymphoma who achieved a complete response following high-dose chemotherapy (HDT) with Autologous stem cell transplant(AHSCT).

NCT ID: NCT01034137 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis

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

This randomized, double-blind, placebo-controlled study will compare the efficacy with regard to sustained remission and safety of tocilizumab and methotrexate, in combination or as monotherapy, in treatment-naïve patients with early rheumatoid arthritis. Patients will be randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or methotrexate plus placebo. Anticipated time on study treatment is 2 years, and target sample size is 300.

NCT ID: NCT01032876 Completed - Clinical trials for Congenital Heart Defects

Cerebral Perfusion During Neonatal Cardiac Surgery

Start date: January 2009
Phase: N/A
Study type: Interventional

Neonates with a congenital heart defect are often in need of early cardiac surgery. In complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without deep hypothermic circulatory arrest (DHCA). The brain is especially vulnerable to ischemic injury, which puts neonates undergoing complex operations at high risk of neurodevelopmental disorders. Selective antegrade cerebral perfusion (ACP) instead of DHCA during these complex operations may contribute to less cerebral damage, but literature is not conclusive on this issue. Therefore, the investigators will perform a randomised controlled trial comparing DHCA and ACP in neonatal aortic arch reconstructions, focusing on cerebral damage and neurological outcome.

NCT ID: NCT01032629 Completed - Clinical trials for Diabetes Mellitus, Type 2

CANVAS - CANagliflozin cardioVascular Assessment Study

CANVAS
Start date: December 9, 2009
Phase: Phase 3
Study type: Interventional

The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin. The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.

NCT ID: NCT01032239 Completed - Severe Spasticity Clinical Trials

SISTERS: Spasticity In Stroke Study - Randomized Study

SISTERS
Start date: November 2009
Phase: Phase 4
Study type: Interventional

To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.

NCT ID: NCT01031784 Completed - Liver Metastasis Clinical Trials

Radioactive Holmium Microspheres for the Treatment of Liver Metastases

HEPAR
Start date: December 2009
Phase: Phase 1
Study type: Interventional

The HEPAR study is aimed at determining the safety of radioactive holmium containing microspheres for the treatment of tumors in the liver. These microspheres will be administered by infusion in the liver artery using a arterial catheter in the femoral artery.

NCT ID: NCT01028638 Completed - Clinical trials for Metastatic Renal Cell Carcinoma

Vascular Endothelial Growth Factor (VEGF) Imaging Before and During Everolimus Treatment for Renal Cell Carcinoma

Everolimage
Start date: December 2009
Phase:
Study type: Observational

Everolimus indirectly inhibits angiogenesis by reducing VEGF production. VEGF can be non-invasively visualized and quantified with serial 89Zr-bevacizumab PET imaging in patients. The investigators hypothesize that a decline in VEGF early during everolimus treatment in patients with metastatic renal cell carcinoma predicts treatment efficacy. 89Zr-bevacizumab PET scans will be performed at baseline, after 2 and 6 weeks of everolimus treatment in 14 adult patients with metastatic renal cell carcinoma.

NCT ID: NCT01028222 Completed - Melanoma Clinical Trials

A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation

TEAM
Start date: June 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation.

NCT ID: NCT01027949 Completed - Clinical trials for Pulmonary Arterial Hypertension

An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension

FREEDOM-EXT
Start date: January 16, 2007
Phase: Phase 3
Study type: Interventional

This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. The study assessed the long term safety of oral treprostinil and the effect of continued treatment with oral treprostinil on exercise capacity after 1 year of treatment.

NCT ID: NCT01027884 Completed - Clinical trials for Muscular Dystrophy, Duchenne

Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)

DELOS
Start date: July 2009
Phase: Phase 3
Study type: Interventional

The aim of this Phase III study was to assess the efficacy of idebenone on pulmonary function, motor function, muscle strength and quality of life in patients with DMD. Furthermore, the safety and tolerability of idebenone was assessed.