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NCT ID: NCT01877915 Completed - Clinical trials for Coronary Artery Disease

A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure

COMMANDER HF
Start date: September 10, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.

NCT ID: NCT01874002 Active, not recruiting - Clinical trials for Coronary Artery Disease

Prospective Registry to Asses the Long-term Safety and Performance of the Combo Stent

REMEDEE Reg
Start date: June 2013
Phase: N/A
Study type: Observational [Patient Registry]

Patients with stenosis in one or more coronary artery are often treated with a percutaneous coronary intervention (PCI). As part of the PCI treatment a stent is often placed to keep the vessel open over time. The Combo-Stent is a novel stent for use during percutaneous angioplasty. In short, the Combo stent combines a drug eluting technique and an endothelial cell attracting layer. The drug coating is designed to prevent re-narrowing of the stent. The endothelial cell attracting layer is designed to ensure rapid coverage of the stent struts with vascular wall cells. The REMEDEE REGISTRY evaluates the long-term safety and performance of the Combo stent in routine clinical practice. In total 1000 patients will be registered and followed for five years.

NCT ID: NCT01871233 No longer available - Clinical trials for Partial Onset Seizures

An Extended Access Program for Perampanel

Start date: n/a
Phase:
Study type: Expanded Access

The Extended Access Program (EAP) is a managed access programme for Perampanel. The main objective of this EAP is to ensure that patients participating in studies E2007-A001-207, E2007-G000-307, or E2007-G000-235 continue to have access to perampanel until such time perampanel tablets become commercially available for the treatment of Partial Onset Seizures (POS) in the country in which they reside. This EAP will consist of 2 phases: - Screening: The patient will start the program once the Screening assessments are completed and the patient is qualified for participation. - Treatment: Additional assessments, physical examinations, and dosage changes will be clinically determined by the treating physician. Patients will enter this program on the same dose of perampanel that they were receiving at the end of their participation in previous study. Doses of perampanel and of concomitant anti-epileptic drugs (AEDs) can be adjusted (i.e., added,removed, or changed in dose) based on clinical judgment. Treatment will be prescribed as long as clinically appropriate according to the judgement of the treating physician and the approved Summary of Product Characteristics (SmPC). The program will complete in a staggered fashion, country by country, as and when perampanel becomes commercially available for the treatment of POS in each country.

NCT ID: NCT01860638 Completed - Glioblastoma Clinical Trials

A Comparison of Continuous Bevacizumab (Avastin) Treatment or Placebo in Addition to Lomustine Followed by Standard of Care After Disease Progression in Participants With Glioblastoma

Start date: August 19, 2013
Phase: Phase 2
Study type: Interventional

This multicenter, double-blind, placebo-controlled, randomized study will evaluate the efficacy and safety of the addition of bevacizumab treatment to lomustine (in 2nd-line [2L] treatment) and SOC (in 3rd-line [3L] and subsequent lines of treatment) following first-line disease progression (PD1) in participants with newly diagnosed glioblastoma. All enrolled participants will receive 1L treatment with radiotherapy, temozolomide, and bevacizumab. At PD1, eligible participants will be randomized (1:1) to receive 2L treatment with either bevacizumab plus lomustine or placebo plus lomustine. After second-line disease progression (PD2), participants will receive 3L treatment and will continue blinded bevacizumab or placebo with the addition of an SOC agent. Following third-line disease progression (PD3), participants will receive subsequent lines of treatment and will either continue blinded bevacizumab or placebo (at the discretion of the investigator), or switch to open-label bevacizumab (at the choice of the participant).

NCT ID: NCT01846299 Completed - Macular Edema (ME) Clinical Trials

To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

Start date: October 2013
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of 0.5 mg in adult patients with visual impairment due to macular edema (ME).

NCT ID: NCT01844856 Completed - Clinical trials for Complicated Intra-abdominal Infections

Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

IGNITE1
Start date: August 2013
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

NCT ID: NCT01840410 Completed - Clinical trials for Choroidal Neovascularization (CNV)

Assess the Efficacy/Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Choroidal Neovascularization.

Start date: September 2013
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of 0.5 mg in adult patients with visual impairment due to choridal neovascularization (CNV).

NCT ID: NCT01838681 Completed - Clinical trials for Major Depressive Disorder

Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

Start date: June 2013
Phase: Phase 3
Study type: Interventional

To evaluate the maintenance of efficacy and safety during long-term treatment with brexpiprazole as an adjunctive treatment for adult subjects with Major Depressive Disorder (MDD)

NCT ID: NCT01836497 Active, not recruiting - Heart Failure Clinical Trials

SD01 Master Study (Safety and Efficacy Study)

Start date: May 2013
Phase:
Study type: Observational

The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.

NCT ID: NCT01829321 Completed - Ulcerative Colitis Clinical Trials

Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis

Start date: April 2013
Phase: Phase 2
Study type: Interventional

- Approximately 45 patients suffering from mild to moderate ulcerative colitis will be examined for any side effects (safety and tolerability) that may occur when taking GLPG0974 or matching placebo (2:1 ratio) for 28 days. - During the course of the study, patients will also be evaluated for improvement of disease activity by different efficacy measures, the amount of GLPG0974 present in the blood determined (PK) and the effects of GLPG0974 on selected biomarkers (PD) in the blood, colon biopsies and faeces will be explored.