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NCT ID: NCT02965040 Completed - Clinical trials for Impaired Renal Function

A Phase 1 Study of Roxadustat in Subjects With Different Degrees of Renal Function

Start date: December 12, 2016
Phase: Phase 1
Study type: Interventional

For subjects with normal renal function or severely impaired renal function, this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma and urine. For subjects with end stage renal disease (ESRD) on continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD), this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma, urine and dialysate. For subjects with ESRD on hemodialysis (HD) or hemodiafiltration (HDF), this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma, urine and dialysate and also the effect of dialysis on the pharmacokinetics of roxadustat and its main metabolites.

NCT ID: NCT02964650 Completed - Clinical trials for Chronic Heart Failure

Optimising Pacemaker Therapy for Contractility

OPT-C
Start date: June 20, 2017
Phase: Phase 2
Study type: Interventional

The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF). They have also demonstrated in an acute cross-over study that keeping the heart rate in this range (versus standard rate-response programming) in patients with CHF is associated with increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a randomised, placebo-controlled trial whether optimal programming versus standard rate-response programming for 6 months leads to appreciable improvements in exercise time and quality of life, while having no adverse effects on left ventricular function and battery longevity. 60 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic assessment to establish the force frequency relationship and the optimal heart rate for contractility. They will then perform a treadmill walk test and fill out a quality of life questionnaire. They will then be randomised to optimal rate-response settings or standard rate response settings and followed up at 6 months at which point the tests will be repeated.

NCT ID: NCT02964273 Completed - Clinical trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Start date: September 23, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the long term safety of treatment with tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease (ADPKD). The secondary objective is to assess the pharmacodynamics, pharmacokinetics, and efficacy of tolvaptan in the same participant population.

NCT ID: NCT02963766 Completed - Type 2 Diabetes Clinical Trials

A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes

AWARD-PEDS
Start date: December 29, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks.

NCT ID: NCT02963142 Completed - Pneumonia Clinical Trials

A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia

S-CAP
Start date: December 2016
Phase:
Study type: Observational

Severe community acquired pneumonia is common and associated with high mortality. Conventional microbiological diagnostics identify pathogens in approximately half of cases, which is inadequate for both clinical and epidemiological purposes. This study applies next-generation sequencing based metagenomic techniques to patients with extremely severe community acquired pneumonia, to investigate the microbiome of severe community acquired pneumonia and evaluate metagenomic approaches as diagnostic tools.

NCT ID: NCT02963116 Completed - Clinical trials for High Risk Coronary Artery Disease

A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (What Does the Body Does to the Drug) of Rosuvastatin to Measure the Relative Bioavailability (the Extent to Which a Drug or Other Substance Becomes Available to the Body) of AZD5718 Oral Suspension vs AZD5718 Immediate Release Tablet

Start date: December 20, 2016
Phase: Phase 1
Study type: Interventional

This study is a randomized, open-label, 5-period, 5-treatment, single-dose, single-center, crossover study to estimate the effect of AZD5718 on the pharmacokinetics (PK) of rosuvastatin, and to assess the relative bioavailability of AZD5718 oral suspension vs AZD5718 immediate release (IR) Tablet Formulation and the Food Effect of AZD5718 in Healthy Volunteers. The study will be performed at a single study center.

NCT ID: NCT02962895 Completed - Clinical trials for Primary Sjogren Syndrome

Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)

Start date: June 27, 2017
Phase: Phase 2
Study type: Interventional

This study will determine the dose-response relationship of VAY736 for key efficacy and safety parameters

NCT ID: NCT02962765 Completed - Hemophilia A Clinical Trials

Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ

Start date: January 2015
Phase:
Study type: Observational

Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients) and routine clinical practice. Besides aspects such as general product safety and efficacy, there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor testing in the laboratory.

NCT ID: NCT02961881 Completed - Clinical trials for Non-Hodgkin's Lymphoma

A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma

Start date: September 18, 2017
Phase: Phase 1
Study type: Interventional

Primary Objective: • To evaluate the safety and tolerability of subcutaneous (SC) blinatumomab dose administrations Secondary Objectives: - To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC administrations - To estimate the maximum tolerated dose (MTD) tested for blinatumomab administered subcutaneously - To determine the incidence of anti-blinatumomab antibody formation following SC administration - To evaluate efficacy response following treatment with SC blinatumomab administration Exploratory Objective: - To determine the pharmacodynamics (PD) time profiles for B-and T-lymphocytes as well as cytokine profiles during SC administration - To evaluate efficacy response following treatment with SC blinatumomab administration using Lugano criteria if positron emission tomography-computed tomography (PET/CT) is used for evaluation

NCT ID: NCT02961738 Completed - Depression Clinical Trials

Is Narrative Reformulation During Cognitive Analytic Therapy Helpful?

Start date: January 2011
Phase: Phase 2/Phase 3
Study type: Interventional

Narrative reformulation (NR) is an active ingredient of cognitive analytic therapy (CAT) which is assumed to increase engagement and improve outcomes. This trial sought to test these claims. A randomized and controlled dismantling trial method has been designed to investigate treatments outcomes for depressed patients receiving CAT in an Improving Access to Psychological Therapies service. Participants will be randomized to either treatment as usual (full-CAT) or CAT minus narrative reformulation (CAT-NR). The primary outcome measure is the Patient Health Questionnaire (PHQ-9), with secondary outcome measures of anxiety, functioning, helpfulness and the alliance. Outcomes will be assessed at screening, every treatment session and at 8-weeks follow-up. The trial will enable as assessment of the utility of NR during CAT. and whether CAT appears suitable for treating depression in Primary Care.