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NCT ID: NCT02293863 Completed - Influenza Clinical Trials

A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection

Start date: January 14, 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study that will investigate the safety and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm of placebo with oseltamivir.

NCT ID: NCT02281318 Completed - Asthma Clinical Trials

Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Participants With Severe Eosinophilic Asthma on Markers of Asthma Control

Start date: December 11, 2014
Phase: Phase 3
Study type: Interventional

This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in participants with severe eosinophilic asthma on markers of asthma control. The overall intent of the current study is to more fully explore the impact of mepolizumab on health-related quality of life (HR-QoL) and other measures of asthma control, including lung function. Participants who meet the predefined criteria will be randomised to receive either mepolizumab or placebo in addition to standard of care asthma treatment. Approximately 780 participants with severe eosinophilic asthma will be screened to ensure the randomisation of 544 participants (272 participants per treatment group) into the study.

NCT ID: NCT02273973 Completed - Breast Cancer Clinical Trials

A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)

Start date: November 12, 2014
Phase: Phase 2
Study type: Interventional

This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.

NCT ID: NCT02270450 Completed - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction

Start date: March 9, 2015
Phase: N/A
Study type: Interventional

This partially randomized clinical trial studies surgery or non-surgical management in treating patients with intra-abdominal cancer and bowel obstruction. Bowel obstruction is a common problem for advanced cancer patients and can negatively affect quality of life. It is not yet known whether surgery or non-surgical management is the best treatment option for bowel obstruction and can lead to better quality of life.

NCT ID: NCT02265744 Completed - Lupus Clinical Trials

Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus

Start date: November 13, 2014
Phase: Phase 2
Study type: Interventional

Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

NCT ID: NCT02260791 Completed - Clinical trials for Arthritis, Rheumatoid

A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients

ARABESC
Start date: December 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have inadequate disease control on methotrexate.

NCT ID: NCT02258542 Completed - Asthma Clinical Trials

A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA

BORA
Start date: November 19, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.

NCT ID: NCT02257385 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Comparative Study of Umeclidinium/Vilanterol (UMEC/VI) in a Fixed Dose Combination With Indacaterol Plus Tiotropium

Start date: October 15, 2014
Phase: Phase 3
Study type: Interventional

This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram [mcg] Once daily [QD]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a treatment period of 12 weeks in participants with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to demonstrate that UMEC/VI (delivered via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD participants, is non-inferior to the combination of indacaterol (delivered via BREEZHALER® inhaler) plus tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced expiratory volume in one second (FEV1) after 12 weeks of treatment. Participants who met the eligibility criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior to randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and week 12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis AG.

NCT ID: NCT02247804 Completed - Ocular Hypertension Clinical Trials

Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension

Start date: December 15, 2014
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.

NCT ID: NCT02247531 Terminated - Geographic Atrophy Clinical Trials

A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

SPECTRI
Start date: October 6, 2014
Phase: Phase 3
Study type: Interventional

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).