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NCT ID: NCT01464476 Terminated - Clinical trials for Cardiovascular Diseases

Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)

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

This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)

NCT ID: NCT01463410 Terminated - Clinical trials for Acute Myeloid Leukemia (AML)

Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler

Start date: October 2011
Phase: N/A
Study type: Observational

This clinical study will demonstrate the accuracy of the chromosomal aberration and gene mutation markers of the AMLProfiler molecular diagnostic assay and generate clinical performance data to support a Pre-Market Approval (PMA) submission to the Food and Drug Administration for in vitro diagnostic use within the United States of America. The objective is to demonstrate the positive and negative percent agreement of each marker by comparing AMLProfiler results from multiple clinical participating sites with data generated using a laboratory developed bi-directional sequencing method generated at the molecular diagnostic reference lab. The AMLProfiler assay is a qualitative in vitro diagnostic test for the detection of AML or APL specific chromosomal aberrations (specific recurrent translocations and inversions), as well as expression of specific genetic markers in RNA extracted from bone marrow aspirates of patients with Acute Myeloid Leukemia.

NCT ID: NCT01462721 Terminated - Clinical trials for Coronary Artery Disease

The eSVS® Mesh Randomized Post-Market Study

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

The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.

NCT ID: NCT01459913 Terminated - Clinical trials for Hepatitis C, Chronic

Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype

CONCISE
Start date: November 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.

NCT ID: NCT01458548 Terminated - Clinical trials for Post-transplantation Lymphoproliferative Disorder

Sequential Treatment of CD20-positive Posttransplant Lymphoproliferative Disorder (PTLD)

Start date: December 2002
Phase: Phase 2
Study type: Interventional

Post-transplantation lymphoproliferative disorder (PTLD) develops in one to ten per cent of transplant recipients and can be EBV-associated. To improve long-term efficacy after rituximab monotherapy and to avoid the toxicity of CHOP seen in first-line treatment, the investigators initiated an international multicentre phase II trial to test whether the subsequent application of rituximab and four courses of three-weekly CHOP would improve the outcome of patients with PTLD: PTLD-1, sequential treatment (ST).

NCT ID: NCT01458015 Terminated - Clinical trials for Peripheral Neuropathy

Tapentadol Versus Oxycodon - a Mechanism-based Treatment Approach in Neuropathic Pain

Start date: October 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to elucidate whether the additional mechanism of analgesia, i.e. reuptake inhibition of norepinephrine, of tapentadol leads to a change in different pain signs and symptoms in comparison to oxycodone.

NCT ID: NCT01452347 Terminated - Clinical trials for Heart Valve Diseases

Dabigatran Etexilate in Patients With Mechanical Heart Valves

RE-ALIGN
Start date: October 2011
Phase: Phase 2
Study type: Interventional

To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.

NCT ID: NCT01449175 Terminated - Emphysema Clinical Trials

A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

Start date: January 2011
Phase: N/A
Study type: Observational

The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.

NCT ID: NCT01447758 Terminated - Atopic Dermatitis Clinical Trials

Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis.

Start date: September 2011
Phase: Phase 1
Study type: Interventional

The purpose of this Phase Ib study is to investigate the safety, tolerability and pharmacokinetics of LEO 29102 2,5 mg/g cream when treating atopic dermatitis (AD) lesions from 10 up to 100% of the body surface area (BSA) twice daily (BID) for 7 days (Cohorts I, II, III) and from 10% up to 50% of BSA (bid) for 6 weeks (Cohort IV). This trial will be performed in four cohorts. Cohort I, II and III includes patients with a larger BSA that increases from one cohort to the next. After each cohort (Cohort I, II)a blinded evaluation of the safety and tolerability data will assess whether a stepwise increase in the percentage of "to be treated BSA" is justified. Cohort IV will start dosing after finalisation of Cohort II and after submission of data from Cohort I and II to the national authority and IEC for review.

NCT ID: NCT01445197 Terminated - Hemophilia A Clinical Trials

Study of Biostate for Treatment of Children With Hemophilia A Complicated by Antibody Development

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

This is a clinical study to investigate how well Biostate works in treatment of male patients below the age of 12 years who have a clotting factor deficiency that is aggravated by the development of antibodies. The antibodies are directed against the clotting factor that is given for replacement therapy and usually make therapy unsuccessful. The treatment used in this study is called immune tolerance therapy.