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NCT ID: NCT02900378 Completed - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure

OUTSTEP-HF
Start date: December 20, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary physical activity in HFrEF patients. Physical activity was assessed by the 6 minute walk test, and daily physical activity was continuously measured by means of a wrist-worn accelerometry device from 2 weeks before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).

NCT ID: NCT02892344 Completed - Mild Asthma Clinical Trials

Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma

Start date: January 16, 2017
Phase: Phase 3
Study type: Interventional

The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d. delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study was to assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.

NCT ID: NCT02888379 Completed - Ulcerative Colitis Clinical Trials

Phase 2a Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Ulcerative Colitis

TOP2
Start date: September 2016
Phase: Phase 2
Study type: Interventional

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity

NCT ID: NCT02878330 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.

MEDI8897 Ph2b
Start date: November 3, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.

NCT ID: NCT02863419 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus

PIONEER 4
Start date: August 10, 2016
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral Semaglutide versus Liraglutide and versus Placebo in Subjects with Type 2 Diabetes Mellitus.

NCT ID: NCT02849626 Completed - Clinical trials for Partial-Onset or Primary Generalized Tonic-Clonic Seizures

Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures

Start date: November 16, 2016
Phase: Phase 3
Study type: Interventional

This is an open-label, multicenter study with an Extension Phase to evaluate the safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to less than [<] 12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic (PGTC) seizures.

NCT ID: NCT02831608 Completed - Stroke Clinical Trials

Study on the Effect of Influenza Vaccination After Heart Attack on Future Cardiovascular Prognosis

IAMI
Start date: October 2016
Phase: Phase 4
Study type: Interventional

Background. For more than a century a causal link between influenza and cardiovascular disease has been suspected. It is conceivable that influenza may precipitate plaque rupture, increase cytokines with central roles in plaque destabilization and trigger the coagulation cascade. Accordingly, registry studies, case control studies and a few small randomized trials, all underpowered for clinical endpoints, have demonstrated that the risk for acute myocardial infarction (AMI) is increased following respiratory infection and that the risk of stroke and AMI in patients with established cardiovascular disease seem to be reduced following influenza vaccination. In May 2015 a Cochrane review concluded that influenza vaccination may reduce cardiovascular mortality and cardiovascular events but bias and inconsistent results in prior studies require higher-quality evidence to confirm these findings. High costs and little commercial interest in conducting a randomized trial on influenza vaccine in cardiovascular disease stand in the way. Objective. The objective is to document whether influenza vaccination protects against cardiovascular events and death in patients with an AMI or very high risk stable coronary artery disease patients. Methods. Population: 4400 patients with ST-elevation (STEMI), non-ST elevation myocardial infarction (NSTEMI) or very high risk stable coronary artery disease are randomized 1:1 in a blinded fashion using an RRCT design and followed up via registries and telephone calls. Intervention: Influenza vaccination. Control: Placebo (saline). Outcome: The primary endpoint is a composite of death, myocardial infarction and stent thrombosis till 1 year. Patients will be included in the study in all of Sweden's 7 university hospitals and 5 general hospitals, 4 university hospitals and 1 general hospital in Denmark, in 1 specialized heart center in Norway, 2 university hospitals in Czech Republic, 6 hospitals in Scotland, 1 university hospital in Latvia and 2 hospitals in Bangladesh. Secondary endpoints are time to all-cause death till 1 year, time to cardiovascular death till 1 year, time to stent thrombosis till 1 year, time to revascularization till 1 year, time to myocardial infarction till 1 year, time to cardiovascular death, a new myocardial infarction or stent thrombosis (first occurring) till 1 year, time to stroke, including TIA till 1 year, time to rehospitalization for heart failure till 1 year, time to hospitalization for arrhythmia till 1 year or length of hospital stay (if information is available). From a hypothesis generating perspective we aim to follow up patients through registries beyond 1 year and up to 5 years. The trial has been approved by the ethical committee system (Dnr 2014/264) and the Medical Products Agency (EudraCTnr -2014-001354-42) in Sweden. Perspectives. If a clinical benefit can be demonstrated in this prospective trial influenza vaccination may become an important novel in-hospital therapy for patients with cardiovascular disease and the accompanying direct and indirect societal gains will be profound.

NCT ID: NCT02819635 Completed - Clinical trials for Ulcerative Colitis (UC)

A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Start date: September 26, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.

NCT ID: NCT02814916 Completed - Clinical trials for Bacterial Infections

Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA

Start date: March 31, 2017
Phase: Phase 3
Study type: Interventional

To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.

NCT ID: NCT02813694 Completed - Clinical trials for Community Acquired Pneumonia

Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia

LEAP2
Start date: August 2016
Phase: Phase 3
Study type: Interventional

This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate community-acquired bacterial pneumonia