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NCT ID: NCT01084161 Completed - Hysterectomy Clinical Trials

Study to Evaluate the Efficacy, Safety and Tolerability of N1539

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

To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy

NCT ID: NCT01080391 Completed - Clinical trials for Relapsed Multiple Myeloma

Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

Start date: July 14, 2010
Phase: Phase 3
Study type: Interventional

The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.

NCT ID: NCT01077154 Terminated - Breast Cancer Clinical Trials

Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)

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

This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease recurrence.

NCT ID: NCT01076764 Completed - Clinical trials for Acute Coronary Syndrome

Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy

TAO
Start date: April 2010
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide Secondary Objectives: - To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide - To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide - To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide - To document the safety of Otamixaban as compared to UFH + eptifibatide - To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide

NCT ID: NCT01076374 Completed - Arrhythmia Clinical Trials

MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY

Start date: July 2008
Phase:
Study type: Observational

The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. This study utilizes data collected from the System Longevity Study (SLS).

NCT ID: NCT01076348 Completed - Heart Failure Clinical Trials

Model 4965 Post-Approval Study

Start date: September 1996
Phase:
Study type: Observational

Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).

NCT ID: NCT01076010 Completed - Clinical trials for Advanced Renal Cell Carcinoma

An Extension Treatment Protocol for Subjects Who Have Participated in a Study of Tivozanib Versus Sorafenib in Kidney Carcinoma (Protocol AV-951-09-301).

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

Open-label, multi-center extension treatment protocol to allow access to tivozanib and sorafenib for subjects who have participated on the AV-951-09-301 protocol. Eligible subjects who were randomized to receive sorafenib on AV-951-09-301 and had documented progression of disease will receive a tivozanib dose of 1.5 mg/day. Eligible subjects who were randomized to tivozanib or sorafenib in AV-951-09-301, and displayed clinical benefit and acceptable tolerability to treatment, will continue to receive tivozanib or sorafenib at the same dose and schedule as in AV-951-09-301.

NCT ID: NCT01074944 Completed - Gaucher Disease Clinical Trials

A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease to Evaluate Once Daily Versus Twice Daily Dosing (EDGE)

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

The primary objective of this study is to evaluate the efficacy and safety of once daily (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in patients with Gaucher disease type 1 who have demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638). The secondary objective is to evaluate the pharmacokinetics (PK) of Genz-99067 when eliglustat tartrate (Genz-112638) is administered QD and BID in patients with Gaucher disease type 1 who have demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638).

NCT ID: NCT01073228 Completed - Alzheimer's Disease Clinical Trials

Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer's Disease

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

This study is being conducted to determine the safety and effect on cognitive function of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease.

NCT ID: NCT01070550 Completed - Clinical trials for Hepatitis C, Chronic

PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a)

Start date: June 2007
Phase: N/A
Study type: Observational

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <5000.