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NCT ID: NCT01319487 Completed - Clinical trials for Diabetic Macular Edema

Safety and Efficacy Study of Topical Administration of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

Start date: May 2011
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.

NCT ID: NCT01318993 Terminated - Crohn's Disease Clinical Trials

Open-Label Extension Study of GSK1605786A

SHIELD-3
Start date: April 2011
Phase: Phase 3
Study type: Interventional

An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.

NCT ID: NCT01318941 Completed - Clinical trials for Diabetic Macular Edema

Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

LUMINOUS
Start date: March 2011
Phase: N/A
Study type: Observational

This study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.

NCT ID: NCT01318642 Terminated - Clinical trials for Adenocarcinoma of the Pancreas

Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas

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

This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1). Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.

NCT ID: NCT01318512 Completed - Clinical trials for Kidney Disease, Chronic

An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis

Start date: July 2010
Phase: N/A
Study type: Observational

This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.

NCT ID: NCT01317641 Completed - Prostate Cancer Clinical Trials

Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer

Start date: March 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

NCT ID: NCT01316939 Terminated - Crohn's Disease Clinical Trials

GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

SHIELD-2
Start date: May 2011
Phase: Phase 3
Study type: Interventional

A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.

NCT ID: NCT01315249 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

ILLUMINATE
Start date: March 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

NCT ID: NCT01313143 Completed - Healthy Volunteers Clinical Trials

A Short Term Pharmacokinetic, Pharmacodynamic and Tolerability Study to Compare AOP200704 vs. Esmolol

Start date: March 2011
Phase: Phase 2
Study type: Interventional

Pharmacokinetics, pharmacodynamics and tolerability of AOP200704 infusion is compared to that of Esmolol by measurement of plasma concentrations of AOP200704, esmolol and their metabolites, by assessing the effect of both drugs on dobutamine-induced tachycardia, and by monitoring vital signs, ECG and adverse events.

NCT ID: NCT01310101 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Ofatumumab Added to Dexamethasone in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia

Start date: April 2011
Phase: Phase 2
Study type: Interventional

The rationale of the study is to explore the safety and efficacy of ofatumumab in combination with dexamethasone (O-dex regimen) in patients with refractory/relapsed CLL. Moreover, the hypothesis is that this approach will be able to achieve at least the same response rates compared with R-dex regimens (historical controls; manuscript submitted to Leukemia), while maintaining lower toxicity profile.