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NCT ID: NCT01701817 Completed - Atrial Fibrillation Clinical Trials

Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II)

ORBIT-AF II
Start date: February 20, 2013
Phase:
Study type: Observational

The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is a multicenter, prospective outpatient disease registry to evaluate the utilization of target-specific antithrombotic agents, such as FXa (factor Xa) inhibitors and direct thrombin inhibitors, and associated outcomes. Importantly, the ORBIT AF II registry will permit the collection and analysis of post-approval observational data needed for evaluating the outcomes associated with these new agents when used in broader patient populations outside of clinical studies. The ORBIT-AF II registry will focus on patients with newly diagnosed atrial fibrillation (AF) as well as those who have been recently started on a target-specific oral anticoagulant agent. Taken together, the ORBIT-AF I and ORBIT-AF II registries will offer a broad and contemporary view of AF therapy.

NCT ID: NCT01701401 Completed - Clinical trials for Chronic Hepatitis C Virus

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

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

The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

NCT ID: NCT01701362 Completed - Neuropathic Pain Clinical Trials

Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

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

This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.

NCT ID: NCT01688037 Completed - Tardive Dyskinesia Clinical Trials

NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)

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

The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

NCT ID: NCT01687218 Completed - HIV Clinical Trials

Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel

Start date: September 25, 2013
Phase: Phase 2
Study type: Interventional

MTN-017 is a Phase 2, multi-site, randomized, six-sequence, two three-period, open label crossover study, examining the effects of oral Truvada and reduced glycerin 1% tenofovir gel. The study population will be sexually active, HIV-uninfected males who are 18 years of age or older, who report a history of receptive anal intercourse in the past 3 months. Each of the study product regimens offers different advantages to participants seeking an effective HIV prevention agent. How these relative advantages will compare in terms of safety, acceptability, systemic and local absorption, and adherence will be examined within this study.

NCT ID: NCT01686555 Completed - Lupus Erythematosus Clinical Trials

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)

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

To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.

NCT ID: NCT01683409 Completed - Clinical trials for Diabetic Kidney Disease

A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease

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

This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the treatment of participants with mild to moderate diabetic kidney disease.

NCT ID: NCT01683266 Completed - Clinical trials for Type 1 Diabetes Mellitus

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

EDITION IV
Start date: September 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: - To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus Secondary Objective: - To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of: - Change of HbA1c from baseline to endpoint (scheduled Month 6) - Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM) - Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia) - Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative) - Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period

NCT ID: NCT01682863 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB in Patients With COPD Who Have Moderate to Severe Airflow Limitation

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

This study is to assess the safety and tolerability of two different dose levels of QVA149

NCT ID: NCT01681992 Completed - Measles Clinical Trials

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life

Start date: October 10, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck & Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).