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NCT ID: NCT01569295 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )

Tugela
Start date: June 15, 2012
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)

NCT ID: NCT01569087 Completed - Clinical trials for Chemotherapy-induced Neutropenia

Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Cancer Patients

Start date: May 2012
Phase: Phase 2
Study type: Interventional

BCD-017-2 is an open-label randomized phase II clinical study to compare the incidence of CTCAE grade 3/4 neutropenia after a single administration of recombinant human pegylated filgrastim empegfilgrastim (Extimia®) at a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients receiving myelosuppressive chemotherapy.

NCT ID: NCT01568866 Completed - Multiple Myeloma Clinical Trials

Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients

ENDEAVOR
Start date: June 20, 2012
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.

NCT ID: NCT01568138 Completed - Heart Failure Clinical Trials

Prospective Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy

CONFIGURE-HF
Start date: August 2010
Phase: N/A
Study type: Interventional

The purpose of the study is to determine the safety, and feasibility of a device, which enables LV volume and radius reduction through scar exclusion in patients whose systolic HF is due to ischemic cardiomyopathy. Appropriate subjects will have akinetic or dyskinetic scar located in the antero-septal LV distribution. Use of this device replicates the geometric reconfiguration of the ventricle achieved through surgical Left Ventricular Reconstruction (LVR), but on a beating, unsupported heart, thereby creating the option of avoiding the use of cardiopulmonary bypass pump (CBP).

NCT ID: NCT01566721 Completed - Breast Neoplasms Clinical Trials

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

SafeHER
Start date: May 17, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).

NCT ID: NCT01566162 Completed - Schizophrenia Clinical Trials

A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

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

This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.

NCT ID: NCT01565902 Completed - Hepatic Impairment Clinical Trials

Pharmacokinetics of BAF312 in Patients With Hepatic Impairment

Start date: October 2012
Phase: Phase 1
Study type: Interventional

This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate and severe hepatic impairment compared to healthy control subjects.

NCT ID: NCT01565408 Completed - Clinical trials for Rheumatoid Arthritis

Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis

Start date: March 2012
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety and tolerability of multiple doses of NNC0114-0006 in subjects with rheumatoid arthritis (RA).

NCT ID: NCT01564862 Completed - Clinical trials for Depressive Disorder, Major

Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder

Start date: April 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects of Lu AA21004, once daily (QD), on cognitive dysfunction in patients with major depressive disorder.

NCT ID: NCT01563731 Completed - Stroke Clinical Trials

Optimal Blood Pressure and Cholesterol Targets for Preventing Recurrent Stroke in Hypertensives

ESH-CHL-SHOT
Start date: April 2013
Phase: Phase 4
Study type: Interventional

Stroke is one of the major causes not only of mortality, but of disease burden worldwide, because of residual disability and cognitive decline. Although blood pressure lowering has been clearly shown to be the most effective means for primary and secondary prevention of stroke, the systolic blood pressure (SBP) levels to achieve by treatment in order to optimize prevention results are unknown, and whether SBP levels lower than those usually recommended are accompanied by further or reduced benefits is undecided yet. Likewise, while low-density lipoprotein cholesterol (LDL-C) lowering by statins has been shown to be associated with primary and secondary stroke prevention, whether more intense lowering is or is not of further benefit is unknown. The Stroke in Hypertension Optimal Treatment Trial (ESH-CHL-SHOT) is a factorial 3 x 2 arm, multicenter, randomized clinical trial designed to test the hypothesis that in elderly patients at high risk of recurrent stroke (previous recent stroke or TIA) antihypertensive treatment programs aimed at reducing SBP to the usually recommended values (< 145 to 135 mmHg), to a lower goal (< 135 to 125 mmHg) or to even lower values (< 125 mmHg) will result in progressively greater reductions in recurrent stroke, incidence of cardiovascular outcomes and cognitive decline. Parallely, the preventive efficacy of more and less intense LDL-C reductions will be tested on the same outcomes.