78 results
Primary: To demonstrate the long-term efficacy of treatment with Org 50081, as compared to placebo, on sleep maintenance in patients with chronic primary insomnia as measured by the subjective Total Sleep Time. Primary efficacy endpoint is the…
To investigate safety and tolerability and to collect exploratory efficacy data of long-term treatment with Org 50081 in adult patients with chronic primary insomnia.
There is no formal research hypothesis for this study. The purpose is to evaluate the effects of dapagliflozin on kidney function (GFR) and the changes from baseline in the ambulatory Blood Pressure. The effects of dapagliflozin on red cell mass and…
To demonstrate the superiority of indacaterol 150 µg o.d. in combination with tiotropium 18 µg o.d. versus tiotropium 18 µg o.d. with respect to standardized area under the curve (AUC) for forced expiratory volume in 1 second (FEV1) between 5 min *…
The primary objective of this study is to compare the overall survival (OS) of ramucirumab DP administered in combination with docetaxel versus docetaxel with placebo as therapy for patients with Stage IV non-small cell lung cancer (NSCLC) who have…
To determine non inferiority of two doses of BI 10773 (10 mg/daily and 25 mg/daily) compared to placebo with respect to first occurrence of any of the adjudicated components of the primary composite Major Adverse Cardiovascular Event endpoint (…
Run-in phase I: To confirm the safety and tolerability of BIBF 1120 up to a dose level of 200 mg b.i.d added to a standard dose of cisplatin/gemcitabine in first line NSCLC patients with squamous cell histology. Pharmacokinetics of BIBF 1120 and…
During the last several years, substantial progress has been made regarding the biologic characterization of the acute leukemias. The traditional understanding that myeloid leukemic cells are developmentally similar to their normal hematopoietic…
To assess the efficacy, measured as progression free survival, and safety of Selumetinib in combination with docetaxel, compared to docetaxel alone, in patients receiving second line treatment for KRAS mutation negative locally advanced or…
The main purpose of the study is to evaluate the safety and tolerability (any toxicities and side effects) of SAR405838 and Pimasertib and that includes identifying the maximum safe and tolerable dose of the study drugs. Also to assess the anti-…
To evaluate the efficacy of pasireotide LAR and everolimus alone or in combination in progressive patients with a well differentiated neuroendocrine tumor of the lung or thymus.
To determine the efficacy of olaparib versus placebo on progression free survival (PFS).
Primary Objectives* Compare OS in NSCLC patients with adenocarcinoma histology treated with ganetespib in combination with docetaxel versus docetaxel aloneSecondary Objectives* Compare progression-free survival (PFS) between the 2 treatment arms*…
Primary objective:To compare the effects of AZD7624 vs. placebo on the time to first event of moderate or severe COPD exacerbation or early drop-out related to worsening of COPD symptoms (composite endpoint) in patients with COPD on maintenance…
Primary objectives* To determine the Overall Response Rate (ORR) in patients with (FGFR3MUT) advanced urothelial carcinoma treated with TKI258* To determine the Overall Response Rate (ORR) in patients with (FGFR3WT) advanced urothelial carcinoma…
Primary objective:- To evaluate the effects of a 10 day-course of prednisolon on coagulation and fibrinolysis parameters in patients with mild-moderate astma, patients with severe asthma, and healthy controls.Secondary objectives:- To compare the…
Primary: assess the effect of tralokinumab compared with placebo in patients with active ulcerative colitis by assessment of clinical response, as defined by the Mayo score, at week 8.Other objectives: assess the change in (partial) Mayo scores…
The objective of the current study is to investigate the efficacy, safety and tolerability of BI10773 (25mg once daily) compared to glimepriride (1-4mg daily) given for 104 weeks with a 104-week extention period in patients with type 2 diabetes…
The objective of the proposed study (1237.25) is to evaluate maximal treatment effect in FEV1 and SGRQ after 12-weeks treatment with two different doses of tiotropium + olodaterol FDC (5*g/ 5*g and 5*g/ 2.5*g) by comparison with placebo in patients…
5. Study objective(s) and hypothesis:The aim of this study is to assess the value of early, intensive and efficient treatment of patients with recent acquired arthritis, in preventing progression into destructive RA