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NCT ID: NCT03464136 Completed - Crohn Disease Clinical Trials

Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

SEAVUE
Start date: March 29, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

NCT ID: NCT03464019 Completed - Clinical trials for Paroxysmal Supraventricular Tachycardia

Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxymal Supraventricular Tachycardia (PSVT). NODE 301 [Part 1 and Part 2 (RAPID Study)]

Start date: June 18, 2018
Phase: Phase 3
Study type: Interventional

This is a two-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by patients who experience an episode of paroxysmal ventricular tachycardia (PSVT) in an at-home setting. Part 1 comprised the conduct of the NODE-301 study up to the date of the adjudication of 150th positively adjudicated PSVT episode and Part 2 comprises the conduct of the NODE-301 study after the completion of Part 1. The RAPID Study (NODE-301 - Part 2) will enroll patients enrolled during Part 1 who had not dosed with the double-blind study drug, or had not discontinued the study before the adjudication of the 150th positively adjudicated PSVT episode in Part 1, and patients enrolled into the study following the completion of Part 1. The study will continue for approximately 6 months after the date of the adjudication of the 180th positively adjudicated PSVT episode (the data on which the primary efficacy analysis of RAPID will be conducted). The study will include the following visits: A Screening Visit, A Test Dose Randomization Visit, Monthly Follow-up Visits, A Randomized Treatment Period, A Randomized Treatment Period Follow-Up Visit, An Open-Label Treatment Period, and A Final Study Visit.

NCT ID: NCT03461406 Completed - Clinical trials for Excessive Bleeding During Surgery

A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants

Start date: January 18, 2019
Phase: Phase 3
Study type: Interventional

The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment application (TStart) with no occurrence of rebleeding until the completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure).

NCT ID: NCT03451045 Completed - Cystic Fibrosis Clinical Trials

Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

Start date: December 22, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study at about 100 sites in North America, and Europe. The planned duration of treatment with study drug is 28 weeks. Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.

NCT ID: NCT03449875 Completed - Clinical trials for Abdominal Aortic Aneurysm

Global Post-market Registry for the Treovance Stent-graft.

RATIONALE
Start date: February 5, 2014
Phase:
Study type: Observational [Patient Registry]

Patients with abdominal aortic aneurysms (AAA) suitable for endovascular aortic repair (EVAR) with Treovance were eligible to participate. Main inclusion criteria were: age 18-85 years; infrarenal AAA without significant infrarenal or distal iliac landing neck calcification or thrombus formation; infrarenal or distal iliac landing neck size requirements specified in the instructions for use. Main exclusion criteria: dissection/ruptured aneurysm or prior AAA endovascular or surgical repair. The primary endpoints were standard EVAR criteria.

NCT ID: NCT03449147 Completed - Chronic Cough Clinical Trials

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)

Start date: March 15, 2018
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.

NCT ID: NCT03449134 Completed - Chronic Cough Clinical Trials

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)

Start date: March 14, 2018
Phase: Phase 3
Study type: Interventional

The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.

NCT ID: NCT03448705 Completed - Human Influenza Clinical Trials

Safety of 4Fluart ID Suspension for Injection in Adult Subjects

Start date: January 31, 2018
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safe usability of the study drugs, i.e. 4Fluart ID 1 µg haemagglutinin (HA)/0.1 ml QIV and 4Fluart ID 2 µg haemagglutinin (HA)/0.1 ml QIV in terms of safety concerns emerged. The secondary objective of the study is to further assess safety in terms of safety parameters, as well as to assess the immunogenicity of 4Fluart ID 1 µg haemagglutinin (HA)/0.1 ml QIV and 4Fluart ID 2 µg haemagglutinin (HA)/0.1 ml QIV in terms of immunogenicity parameters.

NCT ID: NCT03444584 Completed - Clinical trials for Type 2 Diabetes Mellitus

Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Participants With Type 2 Diabetes

Start date: May 8, 2018
Phase: Phase 2
Study type: Interventional

A Phase 2 study Comparing the effects on glucose control of MEDI0382 in combination with Dapagliflozin and Metformin compared to placebo in combination with Dapagliflozin and Metformin in overweight/obese participants with Type 2 Diabetes Mellitus (T2DM).

NCT ID: NCT03443869 Completed - CMV Disease Clinical Trials

Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)

Start date: May 3, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.