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NCT ID: NCT02431481 Completed - Clinical trials for Impaired Renal Function

Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011

Start date: October 23, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal renal function.

NCT ID: NCT02429895 Terminated - Psoriatic Arthritis Clinical Trials

A Phase 2, Multicenter Open-Label Extension (OLE) Study With ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197

Start date: October 2015
Phase: Phase 2
Study type: Interventional

A Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197 Phase 2 Randomized Controlled Trial (RCT).

NCT ID: NCT02425644 Completed - Multiple Sclerosis Clinical Trials

Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis

OPTIMUM
Start date: June 4, 2015
Phase: Phase 3
Study type: Interventional

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

NCT ID: NCT02422615 Completed - Clinical trials for Advanced Breast Cancer

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

MONALEESA-3
Start date: June 9, 2015
Phase: Phase 3
Study type: Interventional

The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.

NCT ID: NCT02422186 Completed - Clinical trials for Depressive Disorder, Treatment-Resistant

A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression

TRANSFORM-3
Start date: August 20, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.

NCT ID: NCT02421510 Completed - Clinical trials for Type 1 Diabetes Mellitus

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

inTandem2
Start date: May 2015
Phase: Phase 3
Study type: Interventional

This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

NCT ID: NCT02417129 Terminated - Clinical trials for Lymphoma, Non-Hodgkin

BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma

Start date: April 2015
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, randomized, double-blind, parallel-arm, active comparator trial to evaluate BI 695500 versus rituximab as a first-line immunotherapy treatment in patients with LTBFL. Patients will be randomly assigned in a 1:1 ratio to receive 375 mg/m2 of BI 695500 or rituximab via intravenous (IV) infusion once a week for 4 weeks (total of 4 dosages administered on Days 1, 8, 15, and 22). Disease assessments will be performed at the End of Study (EOS) Visit at Week 30.

NCT ID: NCT02415400 Completed - Clinical trials for Acute Coronary Syndromes

A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart

Start date: June 4, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.

NCT ID: NCT02413398 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes

DERIVE
Start date: June 15, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal impairment.This study will be conducted at approximately 100 centres from countries across North America and European regions. It is planned to randomize a total of 302 patients.

NCT ID: NCT02410200 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS

FOCUS
Start date: September 30, 2015
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate) on brain magnetic resonance imaging (MRI) lesions in pediatric participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics of BG00012 in pediatric participants with RRMS and to evaluate the safety and tolerability of BG00012 in pediatric participants with RRMS.