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NCT ID: NCT03338816 Completed - Clinical trials for Acute Intermittent Porphyria

ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)

Start date: November 16, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1), compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic Porphyrias (AHP).

NCT ID: NCT03332771 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

SOTA-GLIM
Start date: December 1, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in body weight, systolic blood pressure (SBP) in participants with baseline SBP ≥130 millimeter of mercury (mmHg), SBP in all participants, and proportion of participants with at least 1 documented symptomatic hypoglycemic event (≤70 milligrams per deciliter [mg/dL]). - To demonstrate the superiority of Sotagliflozin 400 mg compared to placebo on change in HbA1c, body weight, SBP in participants with baseline SBP ≥130 mmHg, SBP in all participants. - To demonstrate the superiority of Sotagliflozin 200 mg compared to placebo on change in HbA1c. - To demonstrate the non-inferiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. - To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. - To evaluate the safety and tolerability of Sotagliflozin compared to Glimepiride and placebo.

NCT ID: NCT03332017 Active, not recruiting - Clinical trials for Relapsed/Refractory Follicular Non-Hodgkin Lymphoma

A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma

ROSEWOOD
Start date: November 14, 2017
Phase: Phase 2
Study type: Interventional

he purpose of the study is to evaluate the efficacy, safety, and tolerability BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.

NCT ID: NCT03329092 Completed - Clinical trials for Ventilator Associated Pneumonia

A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.

REVISIT
Start date: April 5, 2018
Phase: Phase 3
Study type: Interventional

A Phase 3 comparative study to determine the efficacy, safety and tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) versus Meropenem (MER) ± Colistin (COL) for the treatment of serious infections due to Gram negative bacteria.

NCT ID: NCT03325556 Completed - Clinical trials for Dementia-related Psychosis

Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

Start date: September 27, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment.

NCT ID: NCT03320876 Terminated - Psoriatic Arthritis Clinical Trials

An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.

Start date: July 26, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety, tolerability and efficacy study of filgotinib in subjects with moderately to severely active PsA. It is estimated that approximately 105 subjects will be rolled-over after they have completed the 16 weeks of double-blind treatment in core study GLPG0634-CL-224. Subjects will be administered filgotinib in this study until filgotinib is registered for PsA or until Week 304, whichever occurs first. The LTE study is concluded with a follow-up visit approximately 4 weeks after the last intake of study treatment.

NCT ID: NCT03317444 Completed - Metabolic Acidosis Clinical Trials

Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease

Start date: September 26, 2017
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily. The maximum study duration is anticipated to be up to 16 weeks.

NCT ID: NCT03315364 Active, not recruiting - Clinical trials for Recurrent or Metastatic Breast Cancer

Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy

OPTIMAL
Start date: December 18, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.

NCT ID: NCT03315143 Terminated - Heart Failure Clinical Trials

Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

SCORED
Start date: December 19, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.

NCT ID: NCT03306394 Completed - Clinical trials for Metastatic Colorectal Cancer

A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).

PRECONNECT
Start date: October 18, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC). Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.