24 results
Subjects randomized to the placebo treatment are unlikely to benefit from the study. However, OAB is not a life-threatening disease and it is not expected that a 12 to 15 week exposure to placebo treatment will have a negative impact on disease…
The primary objective of the study is to determine if the treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic…
To determine the efficacy and safety of MEDI4736 evaluated as a single agent or in combination with tremelimumab in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) whose disease has progressed on 5-FU-containing or gemcitabine-…
Primary Objective:To assess the effect of UT-15C sustained release (SR) tablets on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 16) in subjects with PAH.Secondary objective:To…
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…
To determine whether aleglitazar reduces cardiovasculair mortality and morbidity (defined as non-fatal myocardial infarction (MI) and non-fatal stroke) in patients with a recent ACS event and type 2 diabetes.
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.
This study is a proof-of-efficacy, dose finding study of LCI699 in patients with mild-to-moderate uncomplicated essential hypertension in order to assess whether the BP effect, safety and tolerability of LCI699 as compared to those of placebo…
Evaluation of the safety and tolerability of Bevacizumab added to standard induction chemotherapy. Evaluation of the effect of Bevacizumab on the CR rate
To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg, 300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained symptomatic atrial fibrillation (AF duration > 72 hours and &…
The primary objectives of this study are:- To demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in reducing NT proBNP from baseline after 12 weeks of treatment in patients with HFpEF.- To demonstrate that LCZ696…
Primary objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in patients with severe steroid-dependent asthma.Secondary objectives:To evaluate the safety and…
To assess, in patients with non-specific low back pain, lasting for over 3 months, the effect of two doses of olpadronate administered intravenously on low back pain as compared to placebo treatment. Assessment of safety and tolerability are also…
Determine the efficacy and safety (using objective response rate) of tremelimumab in patients with advanced solid tumors (UBC, PDAC, TNBC).
This trial is, along with establishment of the safety, tolerability and pharmacokinetics and -dynamics of CDZ173 in the target population, designed to select the optimal dose to normalize the function of the PI3K protein in patients with APDS/PASLI…
Co-primary (tested in parallel for non-inferiority):-To compare daprodustat to darbepoetin alfa for CV safety (non-inferiority)-To compare daprodustat to darbepoetin alfa for Hgb efficacy(non-inferiority)
Maintenance treatment- To compare progression free survival between maintenance therapy with Ixazomib versus placebo, both following induction therapy with ixazomib citrate * thalidomide * low dose dexamethasone Induction treatment-To determine…
To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to BCG (induction and maintenance) alone in high-risk non-muscle-invasive bladder cancer patients.
The primary objective of this trial is to investigate the proposed beneficial effect of simvastatin on total symptom severity (PANSS) ascompared to placebo when given in addition to antipsychotic medication, and the effects on neurocognitive…
To examine in depressed patients who reach a stable depression remission during optimal AD treatment: 1) whether discontinuation is possible; 2) when discontinuation is possible; and 3) in whom discontinuation is possible.