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NCT ID: NCT01015118 Completed - Ovarian Neoplasms Clinical Trials

LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer

Start date: November 17, 2009
Phase: Phase 3
Study type: Interventional

The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.

NCT ID: NCT01014975 Completed - Clinical trials for Acute Ischemic Stroke

A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients

Start date: November 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg, and 80 mg) are being tested in 3 different groups of patients. Patients are monitored by imaging of the affected artery and functional testing.

NCT ID: NCT01013753 Completed - Asthma Clinical Trials

A Study of the Safety and Efficacy of 4 Doses of BI 1744 CL Delivered Via the Respimat in Patients With Asthma.

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

The primary objective of this study is to determine the efficacy and safety of 4 doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma in comparison to placebo.

NCT ID: NCT01010503 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.

Start date: June 2009
Phase: Phase 4
Study type: Interventional

This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.

NCT ID: NCT01010061 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)

Start date: December 21, 2009
Phase: Phase 3
Study type: Interventional

This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

NCT ID: NCT01009255 Completed - Alzheimer's Disease Clinical Trials

Study to Evaluate the Efficacy and Safety of GSK239512 in Alzheimer's Disease

Start date: November 2, 2009
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512 compared to placebo in patients with mild to moderate Alzheimer's disease

NCT ID: NCT01009047 Completed - Schizophrenia Clinical Trials

An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia

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

The purpose of this study is to evaluate the efficacy and safety of extended-release (ER) paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations [imagining things], and withdrawal into the self) .

NCT ID: NCT01007942 Completed - Clinical trials for Metastatic Breast Cancer

Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer

BOLERO-3
Start date: October 2009
Phase: Phase 3
Study type: Interventional

This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.

NCT ID: NCT01006135 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region

Start date: October 2009
Phase: N/A
Study type: Observational

The objective of this observational study is to collect and evaluate data on Health Related Quality of Life (HRQoL) of Spiriva delivered by HandiHaler, using disease specific SGRQ in the national samples of Central & Central European patients with varying severities of chronic obstructive pulmonary disease (COPD) in the real life setting over the 6 months.

NCT ID: NCT01001377 Completed - Clinical trials for Metastatic Colorectal Cancer

ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

Start date: February 2, 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.