43 results
The primary objective of this trial will be to evaluate the effect of ONO-2506PO (1200 mg once daily) on the slope of respiratory function (slow vital capacity (SVC) expressed as a percentage of the predicted value) over 12 months compared with…
Primary Objective• To evaluate best overall response rate (BORR; CR + PR) in Cohort 1 (TKI-naïve patients).* BORR will be based on investigator assessment, based on the findings on computed tomography (CT) or magnetic resonance imaging, using RECIST…
Primary objective* To demonstrate the effect of ACT-293987 on time to first morbidity and mortality (MM) event in patients with pulmonary arterial hypertension (PAH).Secondary objective * To evaluate the effect of ACT-293987 on exercise capacity and…
PrimaryTo compare progression-free survival (PFS) between tivozanib in combination with mFOLFOX6 and bevacizumab in combination withmFOLFOX6 based on investigator radiological tumor assessmentSecondary• Progression Free Survival (PFS) based on…
Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients withMild Cognitive Impairment Due to Alzheimer*s Disease or Mild Alzheimer's Disease
The primary objective of this study is:To evaluate the efficacy of a regimen containing elvitegravir/emtricitabine/tenofovir disoproxil fumarate/GS 9350 versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV 1…
The objective is to investigate the efficacy and safety of afatinib over placebo when given as adjuvant therapy for patients with no evidence of disease after CRT in primary unresected patients with LA SCC stage III or IVa/b of the oral cavity,…
Non invasive imaging of hypoxia with the aid of PET-scans could help to select the patients having a hypoxic tumor who could be treated with specific anti-hypoxic treatments. The added value of additional anti-hypoxic treatments depends on the…
Primary objective:To evaluate efficacy of RO5185426 as a monotherapy compared to dacarbazine in terms of progression-free survival (PFS) and overall survival (OS) in previously untreated patients with advanced melanoma harbouring the BRAF V600E…
Evaluation the effect of AMG 181 on induction of remission in subjects with moderate to severe UC at week 8 as assessed by a total Mayo Score >= 2 points, with no individual subscore > 1 point.
Primary: To evaluate the long-term safety and tolerability of BIIB017 in subjects originally treated in Study 105MS301 who continue BIIB017 treatment.Secondary: To describe long-term MS outcomes in subjects originally treated in Study 105MS301 who…
To evaluate the efficacy of AMG 181 as measured by the proportion of subjects achieving Crohn*s Disease Activity Index (CDAI) remission (CDAI < 150) at week 8.
Primary: The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with active relapsing MS when used concurrently with Avonex. Secondary: Secondary objectives of this study in this study population are to assess the…
To evaluate the efficacy of ACZ885 plus MTX by assessing the response to treatment (ACR50) as compared to MTX alone in early RA patients after 6, 14 and 26 weeks of treatment. The study aims to evaluate the clinical response in this RA subpopulation…
- to evaluate the safety and tolerability of oral ANA773 tosylate (ANX8414) administered with ribavirin inpatients with chronic hepatitis C viral (HCV) infection· to evaluate the anti-viral and pharmacodynamic effects of ANA773 tosylate (ANX8414)…
Primary:* To demonstrate non-inferiority between the level of agreement in diagnosis (i.e. patient classification of normal, mild/moderate or severe ischemic disease based on the number of reversible perfusion segments) between sequential adenosine…
Primary objective:- To evaluate the safety and tolerability of single ascending doses of ASP3652 in healthy young Caucasian male and female subjectsSecondary objectives:- Different pharmacokinetic outcomes- Different pharmacodynamic outcomes
The aim of this study is to (i) determine if tumor hypoxia can be accurately visualized with [18F] HX4 PET imaging in Cervix tumors (ii) correlate the [18F] HX4 PET images with blood and tissue markers and (iii) investigate the quality and optimal…
Primary Objective:To assess the clinical response rate as measured by American College of Rheumatology 20% (ACR20) response rate at Week 12.Secondary Objective:• To assess:- for all patients at Week 12, and every 8 weeks and at the completion/…