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NCT ID: NCT03943550 Recruiting - Ulcerative Colitis Clinical Trials

Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC)

Start date: May 8, 2019
Phase: Phase 1
Study type: Interventional

The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in participants with active ulcerative colitis.

NCT ID: NCT03906799 Recruiting - Atrial Fibrillation Clinical Trials

Study on OMT-28 in Maintenance of Sinus Rhythm in Patients With Persistent Atrial Fibrillation (AF)

PROMISE-AF
Start date: March 19, 2019
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, dose-finding, placebo-controlled, parallel group, multicenter, phase II study to evaluate the efficacy, safety, and popPK of three different doses of OMT-28 given once daily versus placebo in patients with persistent AF.

NCT ID: NCT03905642 Completed - Cystic Fibrosis Clinical Trials

Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase

Start date: January 8, 2009
Phase: Phase 2
Study type: Interventional

A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of patients with CF in the U.S. are infected. Liposomal amikacin for inhalation (LAI; Arikayce™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and delivery to the lungs of infected patients when delivered via a nebulizer. Because liposome particles are small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit drug close to the bacterial colonies (Meers, et al., 2008) (Clancy, et al., 2013), thus improving the bioavailability of amikacin at the infection site. The clinically achievable doses of amikacin in the LAI formulation can effectively increase the half-life of the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several advantages over current therapies in treating patients with CF with chronic infection caused by P. aeruginosa.

NCT ID: NCT03891173 Recruiting - Lung Adenocarcinoma Clinical Trials

A Study of L-DOS47 in Combination With Vinorelbine/Cisplatin in Lung Adenocarcinoma

Start date: February 19, 2019
Phase: Phase 2
Study type: Interventional

This study will determine the highest dose of L-DOS47 that can be given in combination with vinorelbine/cisplatin, evaluate safety and tolerability of L-DOS47 when given in combination with vinorelbine/cisplatin, and assess how effective this combination is in treating patients with lung adenocarcinoma compared to patients who are given vinorelbine/cisplatin alone.

NCT ID: NCT03882970 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes

SURPASS-3
Start date: April 1, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 59 weeks and may include up to 22 visits.

NCT ID: NCT03878446 Not yet recruiting - Clinical trials for Short Stature Children Born Small for Gestational Age (SGA)

A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

Start date: May 20, 2019
Phase: Phase 2
Study type: Interventional

The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 4 years. Participants will take either an injection once every week or once every day. Participants will have 9 clinic visits and will be in the study for 1 year. The follow-up period is at least 30 days.

NCT ID: NCT03870880 Active, not recruiting - Schizophrenia Clinical Trials

Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension

PRISMA-3_OLE
Start date: August 25, 2017
Phase: Phase 3
Study type: Interventional

This is the long-term open label extension (OLE) of the study PRISMA-3 (NCT03160521). Those patients who complete participation in the main segment of the study (double blind) together with other clinically stable not previously enrolled (de novo patients) may opt to participate in this extension segment, where they will receive active Risperidone ISM® (75 mg or 100 mg)under open-label conditions every four weeks for approximately 12 months.

NCT ID: NCT03869502 Recruiting - Clinical trials for Chronic Myeloid Leukemia in Myeloid Blast Crisis

European CML Blast Crisis Register

BlastCrisis
Start date: October 25, 2018
Phase:
Study type: Observational [Patient Registry]

Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe

NCT ID: NCT03860428 Recruiting - Clinical trials for Patent Ductus Arteriosus

Early Treatment Versus Expectant Management of PDA in Preterm Infants

Start date: February 15, 2019
Phase: N/A
Study type: Interventional

Patent ductus arteriosus (PDA) in very preterm newborns is associated with severe neonatal mor-bidity: intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), necrotizing en-terocolitis (NEC), retinopathy of prematurity (ROP). Existing methods of management PDA do not reduce the incidence of these diseases. The efficacy of cyclooxygenase inhibitors (COX) which are currently the standard of treatment in extreme preterm infants is about 70-80%. COX inhibitors have significant side effects. On the other hand, surgical ligation of the ductus arteriosus is associated with deterioration due to cardio-pulmonary problems and long-term complications. Paracetamol has been proposed for treatment of hemodynamically significant PDA because it has a different mecha-nism of action compared with COX inhibitors and a better safety profile. Recently, expectant approach has becoming more popular, although there is not enough evidence to support it. The objective of this study is to investigate whether in preterm infants, born at a GA less than 32 weeks, with a PDA (diameter > 1.5 mm) at a postnatal age of < 72 h, an expectant management is non-inferior to early treatment with regard to the composite of mortality and/or severe morbidity.

NCT ID: NCT03855865 Not yet recruiting - Clinical trials for Depressive Disorder, Major

Study of Rapastinel as Monotherapy in Major Depressive Disorder (MDD)

Start date: April 22, 2019
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to 10 mg of Vortixetine and placebo in participants with major depressive disorder (MDD).