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NCT ID: NCT02536118 Active, not recruiting - Bradycardia Clinical Trials

Micra Transcatheter Pacing System Post-Approval Registry

Start date: July 2015
Phase:
Study type: Observational [Patient Registry]

Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release. The Micra Registry is conducted within Medtronic's Product Surveillance Registry.

NCT ID: NCT02535728 Completed - Quality of Life Clinical Trials

Anesthesia Geriatric Evaluation and Quality of Life After Cardiac Surgery

AGE
Start date: July 2015
Phase: N/A
Study type: Observational

A prospective observational cohort study to assess the predictive value of preoperative frailty on postoperative quality of life in cardiac surgery patients.

NCT ID: NCT02534896 Terminated - Clinical trials for Active Rheumatoid Arthritis

To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis

Start date: November 2015
Phase: Phase 3
Study type: Interventional

This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation.

NCT ID: NCT02534350 Completed - Clinical trials for Respiratory Syncytial Virus (RSV)

Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection

Start date: December 31, 2015
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.

NCT ID: NCT02533102 Completed - Healthy Subjects Clinical Trials

Pharmacokinetics and Food Effect of Single Oral Dose of E7050 in Healthy Volunteers

Start date: November 2010
Phase: Phase 1
Study type: Interventional

This study is designed to first evaluate the effect of food on E7050's pharmacokinetic parameters following the administration of single 100 mg oral doses of E7050 tablet to each normal healthy participant in the study (Part A), and second to characterize E7050 pharmacokinetics after single doses at 200 mg and 400 mg under fasted conditions (Part B). Part A will be a randomized, single-dose, open-label, three-treatment period crossover study. Part B is a nonrandomized, open-label, two-treatment sequential study design. Twelve participants in Treatment Period 1 will receive a single dose of 200 mg of E7050 under fasted conditions. Following review of safety data of the 200 mg dose level, an additional 12 subjects will then receive a single dose of 400 mg of E7050 in Treatment Period 2.

NCT ID: NCT02532283 Completed - Influenza A Virus Clinical Trials

A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection

Start date: December 11, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to adults (aged 18 to <= 64 years) with influenza A infection.

NCT ID: NCT02531633 Terminated - Clinical trials for Giant Cell Arteritis

Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis

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

Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in the treatment of giant cell arteritis (GCA) by interruption of multiple pathogenic pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in the treatment of active GCA. The study will be conducted in 2 distinct parts (Part A and Part B) and consists of the following phases: Screening phase, Part A: 52-week double-blind treatment phase, Part B: 104-week extension phase with the option to receive open-label sirukumab based on disease status and a 16-week follow-up phase if applicable. Approximately 204 subjects with a diagnosis of GCA and active disease within 6 weeks of baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week 52. Subjects completing Part A of the study will be eligible to enter Part B, the 104-week extension phase, designed to investigate the long-term maintenance of remission and safety following cessation of sirukumab treatment and to assess long-term corticosteroid use. Subjects with active GCA at the end of Part A or those with new onset of GCA flare during the first 52 weeks of Part B will be eligible to receive open-label sirukumab. Subjects will need to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of study drug, applicable only for those who are withdrawn prematurely from the study or whose open-label sirukumab treatment in Part B completes after Week 88.

NCT ID: NCT02531516 Active, not recruiting - Prostatic Neoplasms Clinical Trials

An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

Start date: November 19, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival based on conventional or prostate specific membrane antigen-positron emission tomography (PSMA-PET) imaging evaluated by blinded independent central review (BICR).

NCT ID: NCT02531490 Recruiting - Pre-Eclampsia Clinical Trials

Early Vascular Adjustments During Hypertensive Pregnancy

EVA
Start date: January 1, 2015
Phase: Phase 4
Study type: Interventional

Paradoxical fetal and maternal results of studies have led to inconsistent use of antihypertensive drugs or no treatment at all in mild to moderate gestational hypertension in the Netherlands. However, none of the studies have taken the individual maternal circulatory state or the contemplated blood pressure response into account. Hypertension may be accompanied by high (hyperdynamic vasodilated profile), normal (normodynamic profile) of low (hypodynamic vasoconstrictive profile) cardiac output, and preeclampsia is not restricted to one circulatory profile. Therefore antihypertensive drugs should be viewed upon as correctors of the hemodynamic state rather than solely reducers of blood pressure. Without taking the maternal hemodynamic profile and condition into account, generic antihypertensive treatment can be expected to result in disappointing, inadequate and paradoxical results. The investigators hypothesize that in mild to moderate hypertension, personalized hemodynamically guided antihypertensive therapy (with target systolic and diastolic blood pressure <130/80mmHg), prevents the progression to severe hypertension and/or preeclampsia compared to no treatment, without the alleged side-effects.

NCT ID: NCT02531217 Completed - Clinical trials for Facioscapulohumeral Muscular Dystrophy

Safety, Tolerability, Pharmacokinetics (PK), and Activity of ATYR1940 in Participants With Muscular Dystrophy - Study Extension

Start date: August 13, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the treatment of adult participants with molecularly defined genetic muscular dystrophies.