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NCT ID: NCT01969136 Terminated - Dementia Clinical Trials

Study of the Safety and Effectiveness of Two Doses of Investigational Study Drug EVP-6124 in Subjects With Alzheimer's Disease

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124 compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease currently receiving stable treatment or previously treated with an acetylcholinesterase inhibitor.

NCT ID: NCT01968980 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia

SPIRE-FH
Start date: October 2013
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.

NCT ID: NCT01968733 Completed - Clinical trials for Community-acquired Bacterial Pneumonia

Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

SOLITAIRE-IV
Start date: November 2013
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

NCT ID: NCT01968447 Completed - Prostate Cancer Clinical Trials

Effect of Neuromuscular Block and Arterial PCO2 on Surgical Rating Scale (SRS), Following Reversal With Sugammadex

BLISSS2
Start date: February 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to study the effect of variations in the arterial CO2 concentration during deep neuromuscular block on the surgical conditions as assessed by the surgical rating scale

NCT ID: NCT01968109 Active, not recruiting - Neoplasms by Site Clinical Trials

An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

Start date: November 5, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.

NCT ID: NCT01967979 Completed - Healthy Volunteer Clinical Trials

A Study of the Effect of Multiple Doses of Itraconazole and Fluoxetine on the Pharmacokinetics of a Single Dose of RO5285119 in Healthy Subjects

Start date: October 2013
Phase: Phase 1
Study type: Interventional

This single-center, open-label, one-sequence, 2-period, within-subject study in 2 cohorts will evaluate the effects of multiple doses of itraconazole and fluoxetine on the pharmacokinetics of a single dose of RO5285119 in healthy volunteers. In Cohort 1, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of 14 days, itraconazole on Days 1-8 of Period 2 with coadministration of RO5285119 on Day 4. In Cohort 2, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of 14 days, fluoxetine on Days 1-12 of Period 2 with coadministration of RO5285119 on Day 6.

NCT ID: NCT01967459 Completed - Atherosclerosis Clinical Trials

Effects Vitamin D Suppletion on Postprandial Leukocyte Activation

DOSFEM
Start date: October 2013
Phase: N/A
Study type: Interventional

Administration of vitamin D will have a beneficial effect on postprandial leukocyte activation, oxidative stress and arterial stiffness in vitamin D deficient females. High doses of vitamin D may have a more pronounced effect than low doses.

NCT ID: NCT01966445 Completed - Cancer Clinical Trials

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors

Start date: November 26, 2013
Phase: Phase 1
Study type: Interventional

Human Epidermal Growth Factor Receptor 3 (HER3) expression is seen across a wide variety of solid malignancies and is associated with poor prognosis. Up-regulation of HER3 expression and activity is also associated with resistance to multiple pathway inhibitors. GSK2849330, a monoclonal antibody targeting HER3, is a new agent for subjects whose tumors express HER3. This study is a phase I, first time in human, open-label, dose escalation study. The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2849330 in subjects with advanced HER3-positive solid tumors. The study will be conducted in two parts. Part 1 (Dose-Escalation Phase) will include dose escalation and PK/PD cohorts to evaluate safety, PK, and PD to guide selection of dose regimen(s) for Part 2. In Part 2 (Expansion Cohorts), up to 3 cohorts will be enrolled at the dose regimen(s) selected based on Part 1 data, to evaluate safety in a larger cohort of subjects at the recommended dose regimen and also to evaluate preliminary evidence of clinical benefit.

NCT ID: NCT01966419 Completed - Clinical trials for Hepatic Encephalopathy

Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)

STOP-HE
Start date: January 7, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

NCT ID: NCT01966263 Completed - Clinical trials for Arthroplasty, Replacement, Knee

Fast Track Total Knee Arthroplasty: Local Infiltration Analgesia vs Femoral Nerve Block

Start date: November 2013
Phase: Phase 4
Study type: Interventional

The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.