5224 results
Primary objective1. To demonstrate the efficacy of at least one of three doses of ACT-128800 as compared to placebo in patients withrelapsing-remitting multiple sclerosis (RRMS) on the cumulative number of new gadolinium-enhancing lesionsper patient…
MAIN OBJECTIVESDose escalation study:To establish the safe use of trastuzumab (Synthon BV, the Netherlands) in healthy volunteers at different dose levels up to 6 mg/kg.Bioequivalence study:Demonstrate bioequivalence between trastuzumab (Synthon BV…
To evaluate the safety, tolerability and pharmacokinetics (PK) of TV 1380 in healthy male and female subjects following multiple intramuscular (IM) injections.
The objective of this study is to investigate if use of ONO-5334 has a more positive effect on bone density and biochemical markers of bone turnover than Alendronate (a bisphosphonate) and placebo.
The goal of the proposed study is to build knowledge about the effect of Naltrexone in a regular sample of cannabis addicts in a mid-size town. To accomplish this, we propose to: a) do a double blind randomized controlled trial with Naltrexone in…
The objective of this research is to study satiation effects of aroma-taste interactions in dairy based products.
Objective: To establish the effect of perinatal probiotics on the prevalence of allergic disease at the age of 5 or 6 years.
The primary efficacy objective of this study is:• To evaluate the efficacy of RO4905417 in reducing the procedural damage during PCIThe secondary efficacy and safety objectives of this study are: • To evaluate the changes in other cardiac and renal…
Determinination of the added effects of dietary sodium restriction or diuretic use to antihypertensive and antialbuminuric therapy.
The primary objectives of this study are:Part II: to demonstrate that the time to flare in Part II is higher with canakinumab than with placebo.Part I: to assess if canakinumab allows tapering of steroids as per protocol in at least 25% of…
The primary objective of this study is to confirm the efficacy and safety of Genz 112638 after 39 weeks of treatment in patients with Gaucher disease type 1.The secondary objective of this study is to determine the long term efficacy, safety, and…
- To assess the safety and tolerability of FSH-GEX* following multiple dose administration by subcutaneous injection- To determine the pharmacokinetic profile of FSH-GEX* following multiple dose administration by subcutaneous injection- To assess…
To establish if and how the endocannabinoid system is involved in ADHD and related symptoms. This will be investigated by assessing the acute effects of a cannabinoid agonist (THC) on brain function related to ADHD and ADHD symptoms.
Primary Objective: to investigate the effect of rosuvastatin 20 mg qd on subsequent immune activation markers in treatment-naïve HIV-patients: circulating LPS (LAL assay), TLR mRNA expression in whole blood, circulating IL-6, D-dimer, hsCRP, CD38…
1. Primary Objectives of the study: The primary objectives of this study are to evaluate the efficacy and safety of 2 SC dosing tiers of ustekinumab in the treatment of adolescent subjects * 12 to < 18 years of age with moderate to severe…
- To evaluate the safety and tolerability of ascending single oral doses of ACT-462206 in healthy male subjects.- To investigate the single oral dose PK and PD of ACT-462206 in healthy male subjects.- To investigate dose proportionality across…
To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone.
The study will be performed in 3 parts, Parts 1, 2 , 3. and 4 (DDI). The purpose of the study is to investigate how safe the compound is and how well the compound is tolerated; this will be investigated in all study parts. In Parts 1 and 2, it will…
The primary objective is to assess the clinical efficacy of siltuximab (a chimeric (murine-human) IgG1* mAb that specifically binds human IL-6 with high affinity and prevents its interaction with the IL-6 receptor, glycoprotein (GP) 80),…
The primary objective is to confirm the hypothesis that Maraviroc stimulates immune recovery; the ssecondary objective is to explore, by virologic and immunologic investigations, the underlying mechanisms of this hypothesis.