31 results
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…
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 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.
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.
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…
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 ObjectiveTo evaluate the clinical efficacy of apremilast (30 mg twice daily [BID] and 40 mg BID), compared with placebo, in subjects with active UC.Secondary Objective To evaluate the safety and tolerability of apremilast (30 mg BID and 40…
The primary purpose of the study is to determine the efficacy of AZD2281 compared to placebo in serous ovariancancer platinum sensitive patients and in a defined HRD subset.
Primary Objective- To evaluate the clinical efficacy and safety of oral apremilast (APR) 30 mg twice a day (BID) compared with placebo, in subjects with moderate to severe plaque psoriasis at Week 16.Secondary Objectives- To evaluate the clinical…
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…
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 *…
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…
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.
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.
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…
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…