115 results
The primary objective of this study is:To evaluate the efficacy of a regimen containing GS 9350-boosted Atazanavir versus ritonavir-boosted atazanavir each administered with emtricitabine/tenofovir disoproxil fumarate in HIV 1 infected,…
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…
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…
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…
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…
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…
Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients withMild Cognitive Impairment Due to Alzheimer*s Disease or Mild Alzheimer's Disease
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…
Part I will assess the safety, tolerability and pharmacokinetics of single, escalating doses of ABT-639Part II will assess the effect of food on the pharmacokinetics of single doses of ABT-639Part III will asses the safety, tolerability, and…
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…
- 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)…
The primary objectives of this study are the following:• To evaluate the safety and tolerability of DMOT4039A when administered every 3 weeks or weekly to patients with unresectable pancreatic or platinum-resistant ovarian cancer• To determine the…
To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a recommended…
In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on: Primary: - Alkaline phosphatase (AP) levels - SafetySecondary: - Hepatocellular injury and liver function - Disease-specific and general health…
SADTo evaluate the safety and tolerability of ascending single doses (SAD) of OCR 002 administered as intravenous (IV) infusions in healthy volunteersTo evaluate the plasma pharmacokinetics (PK) of phenylacetate and ornithine and glutamine after a…
Primary objective:* To demonstrate that subjects who receive an 8-day series of Otelixizumab infusions have greater improvement than subjects who receive placebo in endogenous insulin secretion at 12 months after study drug administration. Secondary…