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NCT ID: NCT02515331 Completed - Clinical trials for Patients, Resistant Hypertension

Safety and Efficacy Study of LHW090 in Resistant Hypertension Patients

Start date: November 4, 2015
Phase: Phase 2
Study type: Interventional

The purpose of the present study was to determine whether LHW090 displays the clinical safety and efficacy profile to support further development in patients with resistant hypertension.

NCT ID: NCT02513459 Completed - Crohn Disease Clinical Trials

A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease

Start date: September 16, 2015
Phase: Phase 2
Study type: Interventional

The primary objective of the study was to investigate long-term safety of risankizumab (BI 655066/ABBV-066) in participants with moderately to severely active Crohn's disease who showed a clinical response or remission on previous treatment with risankizumab in Study NCT02031276 (BI trial 1311.6/ AbbVie M15-993) and were now receiving long-term treatment. Additional objectives of this study were to further investigate long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of risankizumab.

NCT ID: NCT02513394 Active, not recruiting - Breast Cancer Clinical Trials

PALbociclib CoLlaborative Adjuvant Study

PALLAS
Start date: August 2015
Phase: Phase 3
Study type: Interventional

This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.

NCT ID: NCT02511366 Completed - Obesity Clinical Trials

Repetitive Brake Activation

Start date: January 2015
Phase: N/A
Study type: Interventional

The appearance of intact macronutrients in the small intestine induces an intestinal brake; a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. Several studies showed that intraileal infusion of nutrients resulted in a reduction in food intake. However only acute effects were investigated in these studies and thus far it is not known whether repetitive (intermittent) infusion results in adaptation to repeated exposure and, thus, a lowered ileal brake response.

NCT ID: NCT02511106 Active, not recruiting - Clinical trials for Stage IB-IIIA Non-small Cell Lung Carcinoma

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

ADAURA
Start date: October 21, 2015
Phase: Phase 3
Study type: Interventional

To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy

NCT ID: NCT02510560 Active, not recruiting - Clinical trials for Premature Birth of Newborn

Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

Start date: December 2016
Phase: Phase 3
Study type: Interventional

The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.

NCT ID: NCT02510508 Terminated - Clinical trials for Alcohol Use Disorder

Group Version of CRAFT Compared to Self-Directed CRAFT Delivery and Non-intervention: a Three-armed RCT

Start date: August 2015
Phase: N/A
Study type: Interventional

The aim of this study is to determine whether a group format Community Reinforcement and Family Training (CRAFT) and Self-Directed CRAFT Delivery are more effective than non-intervention in terms of Concerned Significant Others (CSO) well- being and cost- effectiveness.

NCT ID: NCT02510482 Completed - Clinical trials for Aortic Valve Stenosis

Biological Variation of Cardiac Biomarkers in Aortic Valve Stenosis

Start date: August 2015
Phase: N/A
Study type: Observational

Calcified aortic valve stenosis (CAVS) is a progressive disease and nowadays, the cornerstone in diagnostics and follow-up is echocardiography. Cardiac biomarkers (such as cardiac troponins T and I and NT-pro-BNP) hold promise to fulfil a role in early recognition of complications concerning the aortic valve and decompensation. For this purpose, it is important to assess the normal biological variation (BV) of cardiac biomarkers in CAVS. The assessment of biological variation will contribute to a better understanding of fluctuation of cardiac biomarkers in subjects with stable CAVS. These data will improve monitoring of CAVS using cardiac biomarkers.

NCT ID: NCT02510261 Completed - Amyloidosis Clinical Trials

The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Participants Who Have Already Been Treated With ALN-TTR02 (Patisiran)

Start date: July 16, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of long-term dosing with ALN-TTR02 (patisiran) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).

NCT ID: NCT02509273 Terminated - Clinical trials for Sedation in Intensive Care

Efficacy, Safety and Pharmacokinetic Study of Intravenous Clonidine Versus Midazolam for Sedation in Paediatric Patients

CloSed1
Start date: May 2016
Phase: Phase 3
Study type: Interventional

Closed1 aims to compare the efficacy, safety and pharmacokinetics of clonidine (hydrochloride) to midazolam in the sedation of ventilated children and adolescents (0-18 years) admitted to a paediatric intensive care unit (PICU) and requiring mechanical ventilation and sedation for at least 24 hours. In particular, the proportion of subjects with sedation failure at the maximum possible dose (defined within the study protocol) will be measured. Additionally, the safety and tolerability (including withdrawal effects) of clonidine compared to midazolam will be evaluated. A pharmacokinetic-pharmacodynamic relationship of clonidine for sedation in PICU will be established. Genetic polymorphisms of clinical relevance affecting pharmacokinetics, pharmacodynamics and metabolism will be also identified. Ad hoc paediatric parenteral formulations of clonidine hydrochloride and midazolam will be manufactured. At least 300 subjects will be enrolled from study centres in five European member countries (Czech Republic, Germany, Italy, the Netherlands, and Sweden). The clinical study will enrol critically ill paediatric patients who require mechanical ventilation and sedation. Subjects will be closely followed using standard PICU monitoring of vital functions (continuous assessment of heart rate and peripheral arterial oxygen saturation, intermittent assessment of systolic and diastolic blood pressure), intermittent assessment of pain and depth of sedation, documentation of parameters of mechanical ventilation and intermittent arterial blood gas analysis. The study will be conducted in compliance with the study protocol, Good Clinical Practice (ICH-GCP) and the applicable regulatory requirement(s). In addition, qualified PICU staff will be monitoring subjects around the clock, thus minimising reaction time in case of alarms or deterioration of clinical parameters. This project has received funding from the European Union's Seventh Framework Programme for research, technological development and demonstration under grant agreement n° 602453.