18 results
Primary objective: To investigate whether pharmacokinetics of the recommended dose of inhaled tobramycin, defined as serum tobramycin Area Under the Curve (AUC0-24hr), with the I-neb (75 mg) is equivalent to the PariLCPlus (300 mg) nebuliser in…
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…
Primary objective: To determine the safety of once daily inhalation of the recommended daily dose of tobramycin with the Akita® and the PARI-LC® Plus nebulizer in patients with CF. Systemic absorption can be used as surrogate parameter for safety.…
The first objective to investigate is the pharmacokinetics of DP tobramycin using the Cyclops® at four different dosages. The other objective is the local tolerability of DP tobramycin using the Cyclops® at four different dosages.
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…
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…
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…
To investigate the clinical pharmacokinetics of tobramycin and/or colistin after nasal administration. With this pharmacokinetic parameters the safety of this treatment can be investigated.
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 primary objective of this study is to demonstrate the efficacy of the combination therapy of aliskiren (150 mg and 300 mg) and HCTZ 25 mg in hypertensive patients who do not show sufficient blood pressure response to a 4-week treatment of HCTZ…
The primary objective of the study is to evaluate the efficacy of aliskiren, valsartan and a combination of both drugs versus placebo in lowering levels of NT-proBNP in stabilized patients post ACS
Primary objectives:- To identify whether EBC can be used as a non-invasive method to measure the PK of salbutamol and tobramycin.- To determine whether the relationship in mild-moderate asthmatics between pulmonary lung function parameters and…
Primary objective: To study the pharmacokinetics of gentamicin, tobramycin, vancomycin and ciprofloxacin in morbidly obese patients and compare with normal weight patients. Secondary objectives: To assess the influence of covariates (such as TBW,…
To determine the effect of Pre-OP, in addition to perioperative intravenous antimicrobial prophylaxis on the cumulative incidence of deep surgical site infections (SSI) and/or mortality within 30 days after surgery in patients undergoing elective…
Primary objectives: The main objective of this Post Market Clinical Follow-Up (PMCF) study is to further evaluate and monitor the safety and performance of the *BasIQ-4®* in a population of women delivering in general hospitals in The Netherlands…
The main objectives are to investigate the pharmacokinetic properties of DP tobramycin via the Cyclops® at different dosages in children with CF, together with the local tolerability.