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NCT ID: NCT03521934 Recruiting - Clinical trials for Heart Failure-Type 2 Diabetes Mellitus

Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

Start date: June 11, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo in hemodynamically stable patients with type 2 diabetes (T2D) and heart failure (HF) with left ventricular ejection fraction (LVEF) <50%, after admission for worsening heart failure (WHF). - To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo in hemodynamically stable patients with T2D and HF irrespective of LVEF after admission for WHF. Secondary Objectives: - To demonstrate that, when compared to placebo in the toal patient population, sotagliflozin reduces the total number (i.e., including recurrent events) of the following clinical events: - Cardiovascular death, HHF or urgent HF visit. - To demonstrate that, when compared to placebo, sotagliflozin reduces: - The composite of positively adjudicated sustained ≥50% decrease in eGFR, chronic dialysis, renal transplant or positively adjudicated sustained eGFR <15 mL/min/1.73 m2 in the total patient population. - Cardiovascular death in patients with LVEF < 50%. - Cardiovascular death in the total patient population. - All-cause mortality in patients with LVEF < 50%. - All cause mortality in the total patient population. - To demonstrate the safety and tolerability of sotagliflozin in the total population in this study.

NCT ID: NCT03519945 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

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

This study designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT03518086 Recruiting - Ulcerative Colitis Clinical Trials

An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

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

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

NCT ID: NCT03498521 Recruiting - Clinical trials for Cancer of Unknown Primary Site

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

CUPISCO
Start date: July 10, 2018
Phase: Phase 2
Study type: Interventional

This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum doublet induction chemotherapy.

NCT ID: NCT03492281 Recruiting - 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: February 28, 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: NCT03479372 Enrolling by invitation - Clinical trials for Neovascular Age-related Macular Degeneration

Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD

Start date: April 26, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Double-masked, uncontrolled, multi-center, study in which participants will be randomized to one of 3 doses of topical ocular PAN 90806 administered once daily for 12 weeks.

NCT ID: NCT03466411 Recruiting - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

GALAXI
Start date: April 13, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this program is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

NCT ID: NCT03456076 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

Start date: September 26, 2018
Phase: Phase 3
Study type: Interventional

This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.

NCT ID: NCT03440372 Recruiting - Crohn Disease Clinical Trials

Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Start date: February 27, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.

NCT ID: NCT03426345 Recruiting - Diabetes Mellitus Clinical Trials

Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis Study 02

Start date: February 20, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of Relamorelin compared to placebo in patients with diabetic gastroparesis. Patients will report daily severity scores of their diabetic gastroparesis symptoms.