57 results
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-…
The primary endpoint is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a BRCA1 and/or BRCA2 Mutation and HER2-Negative Metastatic or…
The objectives of the study are as follows:*1. To assess the effectiveness of inhaled PA101 delivered via eFlow high efficiency nebulizer for treating chronic cough. Improvements in chronic cough will be assessed by measuring the change from…
Primary objectiveTo assess safety and tolerability of Neu-P12 in four different single doses of the drug. Secondary objectiveTo compare the pharmacokinetics, pharmacodynamics, safety, and tolerability of different single doses of Neu-P12.
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…
The primary objective of the study is to evaluate the percentage of subjects who do not experience a flare on CZP 200mg Q2W (full-dose) or 200mg Q4W (half-dose) during Part B. The secondary objectives are: 1) to evaluate the percentage of subjects…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…
The primary objective is to demonstrate the efficacy of AR101, a pharmaceutical-grade peanut allergen formulation, through reduction in clinical reactivity to limited amounts of peanut allergen in peanut-allergic children (ages 4-17 years, inclusive…
Patients with hyperlipidemie and an elevated Lp(a) will be asked to partipate in this study. This part potentially increases the risk of cardiovascular diseases. One of the reasons why Lp(a) is expected to increases this risk is that Lp(a)…
1. Primary Objectives• To evaluate the safety and tolerability of VX 440 monotherapy and VX 440 in dual and triple combination with VX-661 and IVA• To evaluate the efficacy of VX 440 monotherapy and VX 440 in dual and triple combination with VX 661…
Primary objectivesPart 1To evaluate the single dose safety and tolerability of donepezil 10 mg when administered with placebo, glycopyrrolate or trospiumPart 2To evaluate the safety and tolerability of donepezil when given with concomitant placebo,…
Primary Objective:To evaluate the efficacy of VX-150 for the treatment of pain caused by small fiber neuropathy.Secondary Objectives:* To evaluate the safety and tolerability of VX-150* To evaluate the pharmacokinetics (PK) of VRT-1207355 and the…
OBJECTIVE AND HYPOTHESISPrimary ObjectiveThe primary objective is to determine whether abiraterone acetate in combination with low-doseprednisone and androgen deprivation therapy (ADT) is superior to ADT alone in improving rPFS and OS insubjects…
Primary Objective: The main objective of this study is to identify a new treatment to alleviate pain and diminish inflammation in patients with hand osteoarthritis with symptoms and signs of inflammation.Secondary Objectives: The secondary…
Primary objective: To determine the efficacy of the combination of olaparib and abiraterone vs placebo and abiraterone by assessment of rPFS (Radiographic progression-free survival) in patients with mCRPC (Metastatic castration-resistant prostate…
Primary ObjectivesPart 1a: To assess the single dose safety and tolerability of ASN120290.Part 1b: To assess the single dose safety and tolerability of ASN120290 in elderly subjects under fasted and fed condition.Part 2: To assess the safety and…
The primary objectives of this study are:· To assess the time to first exacerbation of COPD, measured from the time of randomization The secondary objectives of this study are:· To evaluate the improvement of quality of life by Saint George*s…
The primary objective is to investigate the efficacy of a single intradiscal injection of STA363 into one or two IVDs as compared to placebo by the following primary efficacy endpoint:* Change from baseline at Month 6 in mean pain intensity measured…
The objective of Study M14-675 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg once daily (QD) compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely…
Zie NL samenvatting