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NCT ID: NCT01708629 Terminated - Plaque Psoriasis Clinical Trials

Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects

AMAGINE-3
Start date: September 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

NCT ID: NCT01705808 Terminated - Sepsis Clinical Trials

Administration of Protein C Concentrates in Adult Critically Ill Septic Patients

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

Severe sepsis and septic shock are life threatening medical emergencies and are among the most significant challenges in critical care. Case reports and case series suggest that plasma-derived protein C concentrate may improve the outcome of patients with acquired protein C deficiency. Evidence has accumulated on the clinical relevance of the PC pathway in modulating overwhelming inflammation and preventing coagulation derangements, two key mediators of organ damage, and thus of mortality and morbidity, in sepsis. The experience collected through these studies shows that PC is safe, in that it is not associated with bleeding or severe allergic complications,and possibly useful, at least to improve the coagulation abnormalities brought about by sepsis. Unfortunately, however, all we know comes from case series or case reports or an underpowered randomized controlled study. A randomized clinical trial, adequately powered for mortality or clinically relevant outcome, is necessary to confirm PC efficacy.The aim of this study is to demonstrate that Protein C zymogen has clinically relevant implications in terms of reduction of thromboembolic events, 30 days mortality, length of intensive care and hospital stay, time on mechanical ventilation, length of ICU and hospital stay. The study will also confirm that there is no bleeding concern with the use of Protein C concentrates.The study drug will be administered in the Intensive Care Unit for 72 hours and the patients observed till ICU discharge. Telephone followup will be performed at 30 days and at one year.

NCT ID: NCT01705080 Terminated - Hypertension Clinical Trials

IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN

EnligHTN-II
Start date: January 17, 2013
Phase:
Study type: Observational

The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.

NCT ID: NCT01702558 Terminated - Breast Cancer Clinical Trials

A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC)

TRAXHER2
Start date: December 3, 2012
Phase: Phase 2
Study type: Interventional

This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design, followed by a randomized, open-label Phase 2 part to explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla alone in participants with mBC. The anticipated time on study treatment is until disease progression, intolerable toxicity, withdrawal of consent, or study end.

NCT ID: NCT01697072 Terminated - Gastric Cancer Clinical Trials

First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma

RILOMET-1
Start date: October 2012
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of epirubicin, cisplatin & capecitabine (ECX) with rilotumumab or placebo for untreated advanced MET-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma

NCT ID: NCT01687998 Terminated - Clinical trials for Cardiovascular Diseases

A Study of Evacetrapib in High-Risk Vascular Disease

ACCELERATE
Start date: October 2012
Phase: Phase 3
Study type: Interventional

The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).

NCT ID: NCT01678547 Terminated - Stroke Clinical Trials

Robot Walking Rehabilitation in Stroke Patients

RoboSTROKE
Start date: September 2012
Phase: N/A
Study type: Interventional

Stroke are the main causes of motor disability among adults and are expected to impose an increasing social and economic burden for our Country. The impact of stroke on patients is enormous, with negative ramifications on the persons participation in social, vocational, and recreational activities. It is the primary cause of long-term disability in these countries. At the present stage, it is well known that control of balance during upright standing depends upon the central integration of afferent information from vestibular, somatosensory (proprioceptive, tactile), and visual systems, which constitute a multilink neural network for the control of neck, hip, and ankle joints. More recently, it has been studied at the level of cerebral cortex; vestibular inputs would reach face/neck representation of primary somatosensory cortex and would be then integrated with visual and somatosensory inputs in intraparietal, posterior end of the insula and medial superior temporal cortices. Remarkably, balance impairment and the associated risk of falling represent one of the most prominent and potentially disabling features in stroke subjects. The specific aims of this project are: to verify whether the robotics lower limb treatment with body weight support is more effective than the treadmill treatment in the reduction of motor impairment in Stroke patients, and to improve the quality of the gait and the endurance and to analyze possible improvements in terms of physiological biomechanical gait through analysis of spatio-temporal parameters.

NCT ID: NCT01673386 Terminated - Clinical trials for Metastatic Renal Cell Carcinoma

A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC

TAURUS
Start date: July 2012
Phase: Phase 2
Study type: Interventional

Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC).

NCT ID: NCT01672879 Terminated - Clinical trials for Liver Fibrosis Due to NASH

Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH

NASH
Start date: October 29, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2 phases: - Randomized Double-Blind Phase - Open-Label Phase (optional)

NCT ID: NCT01672866 Terminated - Clinical trials for Liver Fibrosis Due to NASH

Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

Start date: December 5, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH. It will consist of 2 phases: - Randomized Double-Blind Phase - Open-Label Phase (optional)