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NCT ID: NCT01579903 Completed - Hemophilia A Clinical Trials

Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)

Start date: August 2012
Phase: Phase 1
Study type: Interventional

This study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when administered as 2 different dose presentations. The first is the current product vials with prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.

NCT ID: NCT01578850 Completed - Clinical trials for Rheumatoid Arthritis

Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

Start date: July 2012
Phase: Phase 4
Study type: Interventional

To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.

NCT ID: NCT01578655 Completed - Prostate Cancer Clinical Trials

Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer

AFFINITY
Start date: August 2012
Phase: Phase 3
Study type: Interventional

This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.

NCT ID: NCT01577680 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study to Assess the Effects of GSK573719/VI Combination and GSK573719 Monotherapy in Subjects With Moderate Hepatic Impairment and Matched Healthy Volunteers

Start date: March 5, 2012
Phase: Phase 1
Study type: Interventional

This study will assess the safety and pharmacokinetics of GSK573719 and GSK573719/vilanterol combination in healthy subjects and subjects with moderate hepatic impairment. The results of this study will provide guidance on the use of the product in patients with hepatic impairment.

NCT ID: NCT01577173 Completed - Clinical trials for Head and Neck Cancer

A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck

Start date: July 2012
Phase: Phase 2
Study type: Interventional

This phase II, open-label, randomized study will evaluate the efficacy and safety of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2 weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation of progressive disease and upon meeting eligibility criteria. Anticipated time on study treatment is until disease progression or intolerable toxicity occurs.

NCT ID: NCT01576718 Completed - Asthma Clinical Trials

A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications

Start date: April 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older with severe persistent asthma who are uncontrolled on high dose ICS therapy.

NCT ID: NCT01575873 Completed - Clinical trials for Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids

GIOP
Start date: March 28, 2012
Phase: Phase 3
Study type: Interventional

This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.

NCT ID: NCT01575834 Completed - Clinical trials for Postmenopausal Osteoporosis

Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

FRAME
Start date: March 15, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis

NCT ID: NCT01575561 Completed - Bipolar I Disorder Clinical Trials

This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296

PERSISTExt
Start date: June 2012
Phase: Phase 3
Study type: Interventional

This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

NCT ID: NCT01575054 Completed - Muscle Spasticity Clinical Trials

BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity

Start date: May 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb spasticity.