58 results
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…
This study is designed to demonstrate non inferiority of 150 *g o.d. of indacaterol versus tiotropium 18 *g o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment.
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…
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…
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 (…
The present study protocol proposes a novel cGMP Enhancing Therapeutic Strategy (cGETS) to 1) enhance plasma levels of cGMP, 2) to increase cGMP-related control of the myocardial response to low dose dobutamine stress testing, 3) to improve…
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. .
Primary • To investigate the safety and tolerability of long-term treatment with 1.5 mg or 3.0 mg of Org 50081 in elderly outpatients with chronic primary insomnia. Secondary • To collect exploratory efficacy data of long-term treatment with Org…
The purpose of this study is to evaluate the effects of QVA149 300/50, a fixed dose combination of QAB149 300µg and NVA237 50µg, versus placebo and two doses of QAB149 300µg and 600µg, in terms of lung function in patients with moderate to severe…
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 investigate safety and tolerability and to collect exploratory efficacy data of long-term treatment with Org 50081 in adult patients with chronic primary insomnia.
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 *…
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…
The study is designed to compare the 24-h spirometry profile of two doses of indacaterol (150o.d. and 300 *g o.d.) with that of placebo (o.d.) and with tiotropium (18 *g o.d.) as an activecontrol in patients with COPD.
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…
The primary objective of this study is to demonstrate the superior antiviral efficacy of the combination of peginterferon alpha-2a plus telbivudine vs peginterferon alpha-2a monotherapy as demonstrated by HBV DNA non-detectability using the COBAS…
The purpose of the study is to collect long-term data of safety, tolerability, and efficacy to support the submission of marketing authorisation of one-month dosing regimen of degarelix for treatment of prostate cancer.Primary Objective:•To evaluate…