24 results
The primary objectives of this study are to test if aliskiren monotherapy is superior or at least non-inferior to enalapril monotherapy (in the entire study population) and/or to test if aliskiren/enalapril combination is superior to enalapril…
To evaluate in detail the functionality of immune cells in the liver and blood in chronic HCV patients before, during and after treatment with telaprevir, pegylated-IFN-alfa and ribavirin.
Primary objective:To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.Secondary objectives:To determine the ratio of the…
The primary objective of this study is to determine the effects of aliskiren, as compared to ramipril, on renal hemodynamics in overweight/obese and hypertensive patients.
Primary1. To determine whether treatment with an aliskiren-based regimen (in part combined with amlodipine or hydrochlorothiazide) compared to a non-aliskiren based regimen, both on top of non-study BP lowering agents where applicable, reduces the…
The primary objective is to demonstrate the superior efficacy of telaprevir in combination withPeg-IFN alfa-2a and RBV compared to standard treatment in subjects with chronic HCVgenotype 1 infection who failed prior treatment with Peg-IFN plus RBV.…
Primary:To estimate the difference in SVR rates between T12/PR24 and T12/PR48 treatment regimens in subjects who achieve eRVR.Secondary:To evaluate the safety of telaprevir in combination with Peg-IFN-alfa-2a and RBV in treatment-naïve subjects with…
The objectives are:- to provide access to telaprevir for subjects with chronic HCV genotype 1 infection who wererandomized to the control group in the C216 trial and who failed therapy for virologicreasons;- to evaluate efficacy, safety, and…
OBJECTIVES AND HYPOTHESISPrimary ObjectivesThe primary objectives are to determine- the effect of steady-state telaprevir 750 mg every 8 hours (q8h) on the multiple dose pharmacokinetics ofphenytoin 200 mg every 12 hours (q12h) in healthy subjects,…
Primary: To investigate the effects of 300 mg aliskiren on albuminuria in patients with non-diabeticnephropathy treated with ramipril 10 mg and volume intervention.Secundary: Effects of ramipril and ramipril plus aliskiren. Effects on RAAS…
The purpose of this study is to determine whether, in patients with type II diabetes at high risk for cardiovascular and/or renal events, aliskiren at a target dose of 300 mg o.d. compared to placebo, on top of conventional treatment, reduces…
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…
Main objective: * To evaluate the effect and variation of 3 and 12 months treatment with Aliskeren-based versus amlodipine-based antihypertensive treatment on aneurismal FDG- uptakeExploratory objectives: * To explore the effect of 3 and 12 months…
This study involves research and the objective of this study is to investigate the effect of esomeprzole on the single-dose pharmacokinetics (i.e., how a drug moves through the body) of telaprevir. And to obtain additional data regarding the safety…
The primary objective of this 2 year extension study (CSPP100A2340E1) is to provide additional long-term safety data in this patient population as a post marketing commitment to the EMEA. A secondary objective is to provide additional follow-up data…
The objective of this trial is to explore the efficacy, safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg q8h or 1125 mg q12h in combination with Peg IFN alfa2a (…
To provide access to a telaprevir-based treatment to subjects of the Control Group (Group A) of Study VX06-950-106 who stopped treatment due to inadequate response to treatment (according to treatment stopping rules). Safety, tolerability, and HCV…
The first aim of the study is to investigate the effect of telaprevir on the concentration of LPV/rtv and ATV/rtv in the blood and the effect of LPV/rtv and of ATV/rtv the concentration of telaprevir in the blood.The second aim is to investigate the…
To compare to control (Group A) (peginterferon alfa-2a [Peg IFN-*-2a] and ribavirin [RBV] for 48 weeks) the proportion of subjects who achieve sustained viral response (SVR, undetectable HCV RNA 24 weeks after completion of treatment) when given…
The primary objective of this trial is to demonstrate that aliskiren 300 mg, in addition to standard therapy, has superior efficacy compared to placebo in reducing the primary index of adverse cardiac remodeling (defined as the change in LVESV from…