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NCT ID: NCT02106442 Completed - Osteoporosis Clinical Trials

36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets

Start date: May 13, 2013
Phase:
Study type: Observational

The purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in osteoporosis patients in daily medical practice.

NCT ID: NCT02105974 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: April 7, 2014
Phase: Phase 3
Study type: Interventional

This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on lung function (as measured by trough forced expiratory volume in one second [FEV1]) of FF 100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD. ELLIPTA™ is a registered trademark of GlaxoSmithKline.

NCT ID: NCT02105961 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD)

Start date: April 24, 2014
Phase: Phase 3
Study type: Interventional

This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar levels as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects who are at or above the baseline blood eosinophil count of at least 150 cells/microliters who exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized in 1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC. The total duration of subject participation will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.

NCT ID: NCT02105636 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)

Start date: May 29, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.

NCT ID: NCT02105285 Completed - Glaucoma Clinical Trials

Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

Start date: April 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with carteolol long-acting ophthalmic solution in subjects who are insufficiently responsive to carteolol long-acting ophthalmic solution.

NCT ID: NCT02105272 Completed - Glaucoma Clinical Trials

Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

Start date: April 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with latanoprost ophthalmic solution in subjects who are insufficiently responsive to latanoprost ophthalmic solution.

NCT ID: NCT02104947 Completed - Hemorrhage Clinical Trials

Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

Start date: May 6, 2014
Phase: Phase 3
Study type: Interventional

Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

NCT ID: NCT02104817 Completed - Clinical trials for Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)

Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia

STRENGTH
Start date: October 30, 2014
Phase: Phase 3
Study type: Interventional

The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.

NCT ID: NCT02103751 Completed - Healthy Clinical Trials

Determination of Biomarkers of Exposure and Biomarkers of Potential Harm in Asian Adult Cigarette Smokers

Start date: July 2007
Phase:
Study type: Observational

The purpose of this study is to determine biomarkers of exposure to Harmful and Potentially Harmful Constituents (HPHCs) in Cigarette Smoke and cardiovascular-related biomarkers in smokers and non smokers.

NCT ID: NCT02102295 Completed - Gingivitis Clinical Trials

Effects of Antioxidant Dentifrice on Gingivitis

Start date: September 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effect of a dentifrice containing L-ascorbic acid 2-phosphate magnesium salt on gingival inflammation, gingival bleeding and gingival redness.