31 results
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 objectives of this study are as follows:Primary Efficacy Objective:• To assess the effect of PG-760564 on the proportion of patients meeting the American College of Rheumatology 20 response criteria (ACR 20) at 12 weeks;11Secondary Efficacy…
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…
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 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 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 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.
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.
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…
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.
Primary ObjectiveTo assess the effect of ABT-981 on OA knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 16 and synovitis/effusion volume of the index knee using quantitative measures and semi-…
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 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 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…
PrimaryThe primary objective is to evaluate the effect of ABT-981 on pain using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN NR3.1) pain subdomain score, in subjects with erosive hand OA at Week 16.Secundary* Evaluate the safety and…
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 (…
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. .