56 results
To assess the safety and tolerability of adjuvant treatment with olaparib
Primary objective: To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of…
Primary objective:To investigate the safety of turoctocog alfa pegol during continuous use for prevention and treatment of bleeding episodes of previously turoctocog alfa pegol treated severe haemophilia A patients.Secondary objectives:To…
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…
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: 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…
PrimaryTo evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with FXS as assessed by:* Incidence and severity of adverse events and serious adverse events* Changes in vital signs, laboratory assessments, and ECGs*…
Compare if once daily laba/lama treatment with two different dosages shows the same or better result on the 24 hr lungfunction than twice daily treatment of two different dosages with ICS/laba treatment. .
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…
Primary objective:- To assess the safety of concizumab given as multiple s.c. doses to subjects with haemophilia ASecondary objectives:- To assess pharmacokinetics of concizumab in subjects with haemophilia A after multiple s.c. doses- To assess…
Primary objectiveTo evaluate and compare the single-dose pharmacokinetic of turoctocog alfa pegol from the pivotal process with turoctocog alfa pegol from the commercial process, each given as intravenous administrations of 50 U/kg to patients with…
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 (…
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 determine the efficacy of olaparib versus placebo on progression free survival (PFS).
The primary objective is to confirm that bronchodilator monotherapy (tiotropium) plus behavioural modification, bronchodilator combination therapy (tiotropium + olodaterol FDC) plus behavioural modification, and bronchodilator combination therapy (…
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…
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.
The overall objective of this study is to evaluate the efficacy and safety of neoGAA in treatment-naïve patients with LOPD as compared to alglucosidase alfa, when this is administered biweekly for a period of 49 weeks. Also, there is an open-label…