99 results
Primary objective is to determine the plasma pharmacokinetics of ModraCape001 and compare these to the pharmacokinetic profile of Xeloda®.Secondary objectives are:• To determine the AUC in blood plasma of capecitabine and its metabolites 5-dFCR, 5-…
Primary Objective* To demonstrate the efficacy of adjunctive perampanel therapy, compared to placebo on primary generalized tonic-clonic (PGTC)seizuresSecondary Objectives* To evaluate the safety and tolerability of perampanel in subjects with…
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.
To evaluate the radiologic progression-free survival (PFS) of subjects treated with the combination of gemcitabine/docetaxel (G/D) plus MORAb-004 versus G/D plus placebo in subjects with metastatic soft tissue sarcoma (mSTS)Secondary Objectives:* To…
The primary objective is to determine the maximum tolerated dose (MTD) of docetaxel (as ModraDoc001) that can safely be administered to patients with cancer in a bi-daily weekly schedule.
To evaluate the efficacy of romiplostim for the treatment of thrombocytopenia in subjects with international prognostic scoring system (IPSS) low or intermediate-1 risk MDS as measured by the number of clinically significant bleeding events.
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.
The primary aim of the trial is to assess what the optimal treatment regimen for acetylsalicylic acid, a statin and two BP-lowering agents is (administered as in regular care in individual agents, a fixed-dose combination pill administered in the…
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC (2.5/5 µg, 5/5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment.
To quantitatively determine the absorption and excretion of docetaxel (as ModraDoc005 10 mg tablets) after administration of a single low dose and a single high dose of oral docetaxel in combination with ritonavir.
Primary objective: to compare changes in endothelial function in patients with obesity related hypertension after 8 weeks of treatment with aliskiren, moxonidine and HCTZ. Secondary objectives: to compare changes in the following parameters in…
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…
The aim of the study is to compare magnesiumhydroxide and polyethylene glycol/electrolytes with regard to the prevention of constipation and side-effects in palliative care cancer patients starting with opioids.
Primary objective: to compare changes in endothelial function in patients with obesity related hypertension after 8 weeks of treatment with aliskiren, moxonidine and HCTZ.Secondary objectives: to compare changes in the following parameters in…
To evaluate PFS with XL184 treatment as compared with placebo in subjects with unresectable, locally advanced, or metastatic MTC to see if the investigational drug XL184 is effective in delaying the growth of the tumor.
Primary Objective: The primary objective is to evaluate the efficacy of 2 doses ofperampanel (8 and 12 mg) in comparison to placebo given as an adjunctive therapy insubjects with refractory partial seizures.Secondary Objective: The secondary…
The purpose of this study is to compare the effect of AT1001 (migalastat hydrochloride) versus placebo on GL-3 in the kidney.
The primary objective of this study is to quantitatively determine the pharmacokinetics (absorption, distribution, metabolism and excretion) of docetaxel (as ModraDoc003 10mg tablets) after administration of a single dose of oral docetaxel in…
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…
The primary objective of this trial is to compare the effect of three different doses of ONO-8539 with placebo in the mean change of the number of micturitions per 24 hrs from baseline to 12 weeks.The secondary objectives of this trial will be:*To…