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Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON Intergroup trial.

PRIMARY OBJECTIVESthe assessment if survival in grade III glioma without combined 1p/19q loss is improved by - daily temozolomide chemotherapy during radiotherapy - the administration of temozolomide after the end of radiotherapy SECONDARY…

START * Stimulating Targeted Antigenic Responses To NSCLC A multi-center phase III randomized, double-blind placebo-controlled study of the cancer vaccine Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in non-small cell lung cancer (NSCLC) subjects with unresectable stage III disease

Primary objective:* To compare survival duration of all randomized subjects by treatment arm.Secondary objectives of this trial are to compare all randomized subjects by treatment arm for:* Time to symptom progression (TTSP) as measured by the Lung…

Primary stability of cemented vs uncemented stems in revision total knee arthroplasty measured with RSA: a randomised controlled trial.

Which technique, cementing or press-fit implanting, of the tibial and femoral stem of the Legion revision total knee prosthesis provides the most primary stability?

Adalimumab for the treatment of perianal fistulas in Crohnâ¤*s disease more effective alone or combined to ciprofloxacin (ADAFI study)

To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone.

Protocol CV185030: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of Apixaban In Preventing Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation

Primary objective: To determine if apixaban is noninferior to warfarin (INR target range 2.0-3.0) in the combined endpoint of stroke (ischemic or hemorrhagic) and systemic embolism, in subjects with AF and at lease one additional risk factor for…

A randomized phase III study of adjuvant chemotherapy with or without low-molecular weight heparin in completely resected non-small-cell lung cancer patients with high-risk for recurrence: NVALT- 8B.

The primary aim of the study is to investigate whether adding Nadroparin to adjuvant chemotherapy in patients in the poor prognostic group (i.e. high SUV) prolongs recurrence-free survival.

The efficacy of radioguided occult lesion localisation (ROLL) versus wire guided lesion localisation (WGL) in breast conserving surgery for non palpable breast cancer: a randomised controlled trial

To evaluate the efficacy of ROLL versus WGL in breast conserving surgery for non-palpable breast cancer.

Autologous bone marrow-derived mononuclear cells for therapeutic arteriogenesis in patients with limb ischemia
A double blind placebo controlled study in diabetic and non-diabetic patients

To validate and extend findings from the TACT sytudy group as well as our own preliminary data in a randomized, placebo controlled study in patients with and without diabetes.

High-dose versus standard-dose weight-based ribavirin in combination with peginterferon alfa-2a for patients infected with hepatitis C virus genotype 1 or 4

To investigate if high-dose ribavirin in combination with peginterferon alfa-2a can improve outcome in treatment naïve hepatitis C patients with genotype 1 or 4 and a high viral load (>400.000 IU/ml).

Multi-center, open-label, randomized study to assess the safety and contraceptive efficacy of two doses (in vitro 12 µg/24 h and 16 µg/24 h) of the ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) for a maximum of 3 years in women 18 to 35 years of age with an extension of the LCS16 treatment arm up to five years

The objective of this study is to assess the safety, efficacy and pharmacokinetics of 2 doses of LNG, delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 35 years of age during 3 years and with an extension…

A randomized, double-blind placebo-controlled, multicenter phase III study in patients with advanced carcinoid tumor receiving Sandostatin LAR and RAD001 10 mg/Day or Sandostatin LAR and Placebo

To determine whether treatment with RAD001 10 mg/d plus Sandostatin LAR® prolongs the progression free survival (PFS) compared to treatment with Sandostatin LAR® alone in patients with advanced carcinoid tumor.

A 24 month, multi-center, open-label, randomized, controlled study to evaluate the efficacy and safety of concentration controlled everolimus to eliminate or to reduce tacrolimus compared to tacrolimus in de novo liver transplant recipients.

To evaluate the use of concentration-controlled everolimus, with the reduction or the elimination of tacrolimus, to provide superior renal function and to provide non-inferior rates of the composite efficacy endpoint compared to the tacrolimus…

A randomized, double-blind, placebo-controlled, parallel-group study to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality

The purpose of this study is to determine whether, in patients with type II diabetes at high risk for cardiovascular and/or renal events, aliskiren at a target dose of 300 mg o.d. compared to placebo, on top of conventional treatment, reduces…

Rheos(TM) Pivotal Trial, a Study of Baroreflex Hypertension Therapy in Refractory Hypertension.
Amendment 1: Dynamic cerebral autoregulation and lacol pulsewave velocity.
Amendment 2: Investigational Plan , revision D
Amendment 3: Investigational Plan, revision E
Amendment 4: Investigational Plan, revision F

The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos system in subjects with JNC-7 defined stage II hypertension that is resistant to treatment with at least three anti-hypertension agents, one of which is a…

A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence: NVALT-8A

The primary aim of the study is to investigate whether it is possible to select patients by PET in a good prognosis group (i.e. low SUV) who will not benefit from adjuvant chemotherapy.

A MULTICENTER, RANDOMIZED, DOUBLE BLIND, CONTROLLED PHASE 3, EFFICACY AND SAFETY STUDY OF SUNITINIB (SU011248) IN PATIENTS WITH ADVANCED/METASTATIC NON SMALL CELL LUNG CANCER TREATED WITH ERLOTINIB

The purpose of this clinical trial is to test whether treatment of patients with NSCLC with erlotinib plus sunitinib is better than treatment with erlotinib plus placebo. All patients enrolling in this study will receive treatment with erlotinib.

A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH MIDAZOLAM FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT

Primary objective:The study has hierarchical co-primary objectives to demonstrate that:- Firstly: dexmedetomidine is at least as effective as sedation with midazolam and daily sedation stops, in maintaining a target depth of sedation in ventilated…

A randomized, double-blind phase 3 study of gemcitabine plus AG-013736 versus gemcitabine plus placebo for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer

Primary Objective: Compare the overall survival (OS) of patients receiving gemcitabine plus AG-013736 versus gemcitabine plus placebo.Secondary Objectives: 1. Compare the progression free survival (PFS) of patients in each arm;2. Compare the…

A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson's disease (PDD).

The purpose of this study is to provide long-term safety data for Exelon® capsule and transdermal patch treatments, in particular the effect of Exelon® on worsening of the underlying motor symptoms of Parkinson*s Disease (PD), in patients with mild…

A randomized, parallel group, open-label, active controlled, multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer

To show superiority of patupilone in overall survival compared to pegylated liposomal doxorubicin (Doxil®/Caelyx®) in taxane/platinum refractory/resistant patients with recurrentovariancancer.