20 results
The objective of the study is to evaluate the safety profile of denosumab in subjects with Giant Cell Tumor of bone.
Primary:Subjects with salvageable giant cell rich tumors:- To evaluate subjects who do not require surgery during the study- To evaluate subjects who are able to undergo a less morbid surgical procedure compared with the planned surgical procedure…
The primary objective of the trial is to evaluate the risk versus benefit of denosumab in maintenance setting in patients requiring long-use (>1 year) of denosumab. For that purpose, the treatment schedule with reduced dose density (120mg SC…
The primary objective of the study is to evaluate the effect of denosumab 60mg every 6 months (Q6M) compared with Actonel 150mg monthly (QM) on total hip Bone Mineral Density (BMD) at 12 months in postmenopausal women transitioning from previous…
The primary objectives of this study are to test if aliskiren monotherapy is superior or at least non-inferior to enalapril monotherapy (in the entire study population) and/or to test if aliskiren/enalapril combination is superior to enalapril…
This study will be carried out to gain more knowledge about denosumab in patientes with NSCLC. The effect of denosumab in combination with platinum-doublet chemotherapy in patients with NSCLC and the relation with the presence of biomarkers in…
The purpose of this research study is to evaluate how safe and effective Denosumab is, compared with placebo, in delaying the time it takes for cancer to spread to the bones in subjects with early-stage breast cancer at high risk of recurrence.The…
The primary objective in the glucocorticoid-continuing subpopulation of men and women treated with chronic glucocorticoid therapy (>= 7.5 mg daily prednisone or its equivalent for >= 3 months and are planning to continue treatment for…
Primary: To investigate the effects of 300 mg aliskiren on albuminuria in patients with non-diabeticnephropathy treated with ramipril 10 mg and volume intervention.Secundary: Effects of ramipril and ramipril plus aliskiren. Effects on RAAS…
To study the long term safety (up to 5 years) of denosumab in subjects undergoing androgen-deprivation therapy for non-metastatic prostate cancer.
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…
The primary objective of this study is to determine the effects of aliskiren, as compared to ramipril, on renal hemodynamics in overweight/obese and hypertensive patients.
Primary1. To determine whether treatment with an aliskiren-based regimen (in part combined with amlodipine or hydrochlorothiazide) compared to a non-aliskiren based regimen, both on top of non-study BP lowering agents where applicable, reduces the…
Main objective: * To evaluate the effect and variation of 3 and 12 months treatment with Aliskeren-based versus amlodipine-based antihypertensive treatment on aneurismal FDG- uptakeExploratory objectives: * To explore the effect of 3 and 12 months…
To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with advanced cancers and bone metastases (or lytic bone lesions from multiple myeloma).SRE is…
The primary objective of this study is to demonstrate the efficacy of the combination therapy of aliskiren (150 mg and 300 mg) and HCTZ 25 mg in hypertensive patients who do not show sufficient blood pressure response to a 4-week treatment of HCTZ…
The primary objective of the study is to evaluate the efficacy of aliskiren, valsartan and a combination of both drugs versus placebo in lowering levels of NT-proBNP in stabilized patients post ACS
To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in subjects with advanced breast cancer and bone metastases.
To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in men with hormone-refractory prostate cancer and bone metastases.
The primary objective of this 2 year extension study (CSPP100A2340E1) is to provide additional long-term safety data in this patient population as a post marketing commitment to the EMEA. A secondary objective is to provide additional follow-up data…