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NCT ID: NCT01485991 Completed - Hepatitis C Clinical Trials

TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy

ATTAIN
Start date: February 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.

NCT ID: NCT01485601 Completed - Clinical trials for Glabellar Frown Lines

Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines

Start date: December 7, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find an optimal dose to determine the safety and tolerability of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular injection in subjects with glabellar lines compared with the standard dose of BOTOX®

NCT ID: NCT01484977 Completed - Epilepsy Clinical Trials

eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam

VERVE
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects not well controlled on their current regimen.

NCT ID: NCT01484275 Completed - Clinical trials for High-risk Smoldering Multiple Myeloma

A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma

Start date: March 1, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of siltuximab compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in patients with high-risk smoldering multiple myeloma (SMM).

NCT ID: NCT01483742 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis

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

This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.

NCT ID: NCT01483690 Terminated - Clinical trials for Acute Lymphoblastic Leukemia

A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL

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

This is a pilot study using decitabine and vorinostat before and during chemotherapy with vincristine, dexamethasone, mitoxantrone, and peg-asparaginase in pediatric patients with acute lymphoblastic leukemia (ALL).

NCT ID: NCT01483560 Completed - Clinical trials for Diabetes Mellitus, Type 1

REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)

REMOVAL
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The trial is conducted in the United Kingdom (UK), Australia, Canada, Denmark and the Netherlands. The aim is to test whether 3 years treatment with metformin added to titrated insulin therapy (towards target HbA1c 7.0%/53 mmol/mol) reduces atherosclerosis, as measured by progression of carotid intima-media thickness (cIMT), in adults with confirmed type 1 diabetes aged 40 years and over at increased risk for cardiovascular disease.

NCT ID: NCT01483053 Not yet recruiting - Clinical trials for Major Depressive Disorder (MDD)

Cardiovascular Effects of Agomelatine and Escitalopram in Patients With Major Depressive Disorder (MDD)

Start date: January 2014
Phase: Phase 4
Study type: Interventional

There is strong evidence that patients with major depressive disorder (MDD) are at increased risk of developing coronary heart disease (CHD). This elevated risk is independent of classical risk factors such as smoking, obesity, hypercholesterolemia, diabetes and hypertension. The risk of CHD is increased 1½-2 fold in those with minor depression and 3-4½ fold in subjects with MDD. Put simply, the relative risk of developing CHD is proportional to the severity of the depression. While the mechanism of increased cardiac risk attributable to MDD is not known disturbances in autonomic function most likely do play a part. In untreated patients with MDD (with no underlying CHD) the investigators have identified that a marked sympathetic nervous activation and diminished heart rate variability (HRV) occurs in a proportion (approximately one third) of patients. Diminished HRV has been linked to increased incidence rates of acute cardiac events in conditions such as hypertension, diabetes and myocardial infarction. Importantly, whether treating depression actually improves the risk of: (1) CHD development or (2) recurrence of cardiac events in patients with existing CHD remains unknown. The investigators, and others, have provided a growing body of evidence linking elevated sympathetic activity and exaggerated sympathetic responses to stress to early stages of end organ dysfunction and markers of disease development. Of particular note, in addition to possible effects on HRV is the association of chronic sympathetic nervous activation to: (a) abnormal blood pressure regulation and (b) the development of insulin resistance. The investigators therefore plan to examine the cardiovascular effects of two different antidepressant medications, agomelatine and escitalopram, in patients with MDD. In addition, the investigators plan to investigate the effects these two medications have on sympathetic nervous system activity, blood pressure, HRV, endothelial function, metabolic and psychological effects. Findings from this study will assist us to identify of biological correlates of sympathetic nervous activation which will enable us to: (1) identify those at potentially increased cardiac risk, and (2) potentially implement additional therapeutic strategies in order to reduce cardiac risk. Indeed, it is not known whether antidepressant treatment alone would be sufficient to reverse any adverse effects of sympathetic nervous activation. This study aims to answer this important clinical question.

NCT ID: NCT01482962 Completed - Clinical trials for Relapsed Peripheral T-Cell Lymphoma

Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

Start date: June 11, 2012
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available.

NCT ID: NCT01482819 Completed - Myopia Clinical Trials

Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

Start date: October 1, 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.