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NCT ID: NCT03610646 Completed - Clinical trials for Diabetic Macular Edema

Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)

DME
Start date: August 23, 2018
Phase: Phase 3
Study type: Interventional

Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. The primary endpoint is mean change from baseline in Best Corrected Visual Acuity (BCVA) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Pharmacokinetics (PK) and immunogenicity to be evaluated in the subjects participating in the study.

NCT ID: NCT03595566 Completed - Clinical trials for Clostridioides Difficile Infection

To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

Ri-CoDIFy 2
Start date: January 28, 2019
Phase: Phase 3
Study type: Interventional

Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin.

NCT ID: NCT03575871 Completed - Dermatitis, Atopic Clinical Trials

Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

JADE Mono-2
Start date: June 29, 2018
Phase: Phase 3
Study type: Interventional

B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

NCT ID: NCT03574597 Completed - Obesity Clinical Trials

Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity

SELECT
Start date: October 24, 2018
Phase: Phase 3
Study type: Interventional

The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.

NCT ID: NCT03560739 Completed - Multiple Sclerosis Clinical Trials

A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients

Start date: September 11, 2018
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby establish a bridge between the ongoing Phase 3 program and the to-be-marketed drug-device combinations

NCT ID: NCT03551626 Completed - Malignant Melanoma Clinical Trials

Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes

COMBI-APlus
Start date: August 29, 2018
Phase: Phase 3
Study type: Interventional

The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.

NCT ID: NCT03517540 Completed - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis

TANDEM
Start date: September 11, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.

NCT ID: NCT03504228 Completed - Clinical trials for Carotid Artery Stenosis

Prospective Single Arm CAS - ROADSAVER Study

ROADSAVER
Start date: January 23, 2018
Phase:
Study type: Observational

Approximately 2000 patients eligible for elective treatment with a Carotid Stent according to hospital routine practice in centers across Europe will be enrolled in the study. The maximum number of patients enrolled at each site will be not limited. Follow-ups are scheduled at discharge, 30 days, and 1 year, as per local practice. Each patient will have follow-up contacts via hospital visit and/or telephone.

NCT ID: NCT03492281 Completed - Overactive Bladder Clinical Trials

A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)

Empowur
Start date: March 26, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.

NCT ID: NCT03481660 Completed - Clinical trials for Diabetic Macular Edema

A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

KITE
Start date: July 27, 2018
Phase: Phase 3
Study type: Interventional

This was a Phase III, randomized, double-masked, multi-center, active-controlled, two-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg compared to the active control, aflibercept 2 mg used per authorized label, in subjects with visual impairment due to diabetic macular edema (DME).