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NCT ID: NCT01978548 Completed - Alzheimer Disease Clinical Trials

A Study to Evaluate the Effects of JNJ-54861911 on Amyloid Beta Processing in Cerebrospinal Fluid and Plasma in Patients With Prodromal Alzheimer's Disease

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

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-54861911 in patients with prodromal Alzheimer's disease (pAD).

NCT ID: NCT01977651 Completed - Clinical trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide

UPWARD
Start date: September 25, 2013
Phase: Phase 4
Study type: Interventional

The objective of this study was to evaluate the incidence of seizures and monitor the safety of enzalutamide treatment in participants with metastatic castration-resistant prostate cancer (mCRPC) known to have risk factor(s) for seizure.

NCT ID: NCT01977573 Completed - Anaemia Clinical Trials

A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)

Start date: October 31, 2013
Phase: Phase 2
Study type: Interventional

This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the control arm. For those randomized to the control arm, the decision around whether the subject requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose to achieve and maintain Hgb concentrations within the target range should be based on Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value being considered. The study consists of a screening phase of at least 4 weeks, a 24-week treatment phase and a follow-up visit that will occur approximately 4 weeks after completing treatment. It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

NCT ID: NCT01977482 Completed - Anaemia Clinical Trials

Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia

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

This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD) who are switched from a stable dose of recombinant human erythropoietin (rhEPO). The data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

NCT ID: NCT01977443 Completed - Clinical trials for Viral Conjunctivitis

Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)

Start date: November 2013
Phase: Phase 2
Study type: Interventional

A randomized, double-masked, placebo-controlled, multi-centre phase IIa proof-of-concept study to evaluate efficacy and safety of APD-209 Eye drops for treatment of acute phase adenovirus-induced EKC. The aims of the study are to investigate the therapeutic efficacy of APD-209 Eye drops as measured by adenoviral load, time to viral eradication, clinical resolution of EKC (objective and subjective assessments), presence of opacities, visual acuity and frequency of second eye infections, and to assess the safety and tolerability of APD-209 Eye drops in EKC infected eyes.

NCT ID: NCT01977014 Completed - Clinical trials for Pulmonary Hypertension Group 1 and 4 According to Nice Classification

NIMS- New Implantable Pump in Pulmonary Arterial Hypertension, a Safety Follow up

Start date: October 2013
Phase: N/A
Study type: Observational [Patient Registry]

This observational study aims to chart patients which get their prostacyclin treatment via the subcutaneous LenusPro pump. How the surgical procedure is performed and the clinical follow-up of these patients. And by this also charting complications that might occur in relation to treatment. Participating centres are located in Denmark, Norway and Sweden.

NCT ID: NCT01976559 Completed - Hydrocephalus Clinical Trials

Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol

Start date: November 2013
Phase: N/A
Study type: Interventional

This research is being done to determine the accuracy of two noninvasive methods of measuring the pressure of the spinal fluid, also known as intracranial pressure (ICP).

NCT ID: NCT01976533 Active, not recruiting - Clinical trials for Eisenmenger Syndrome

Eisenmenger Syndrome in the Nordic Countries

Start date: October 2012
Phase: N/A
Study type: Observational

This is a historical cohort study with retrospective collection of data comprising all Nordic patient's diagnosed with Eisenmengers syndrome in the period 1977 through 2011. The goal is to determine prognostic factors for mortality and morbidity.

NCT ID: NCT01976052 Completed - Clinical trials for Obstructive Sleep Apnea

Evaluation of Potential Biomarkers for Obstructive Sleep Apnea and the Effect of Positive Pressure Treatment

Start date: October 1, 2013
Phase:
Study type: Observational

Potential biomarkers for obstructive sleep apnea (OSA), and full genomic screening will be evaluated and correlated to the degree of OSA and to effect of CPAP-treatment measured by polygraphy.

NCT ID: NCT01975389 Terminated - Clinical trials for Cardiovascular Disease

The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects

SPIRE-2
Start date: October 29, 2013
Phase: Phase 3
Study type: Interventional

This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL (3.4 mmol/L).