12 results
Primary: To demonstrate the long-term efficacy of treatment with Org 50081, as compared to placebo, on sleep maintenance in patients with chronic primary insomnia as measured by the subjective Total Sleep Time. Primary efficacy endpoint is the…
To investigate safety and tolerability and to collect exploratory efficacy data of long-term treatment with Org 50081 in adult patients with chronic primary insomnia.
To study the protective effect of pre-treatment with metformin on flow mediated dilation after 20 minutes ischemia and 20 minutes reperfusion. If metformin treatment indeed limits endothelial IR-injury, a second study will be performed in the same…
The present study protocol proposes a novel cGMP Enhancing Therapeutic Strategy (cGETS) to 1) enhance plasma levels of cGMP, 2) to increase cGMP-related control of the myocardial response to low dose dobutamine stress testing, 3) to improve…
The primary objective of this study is to evaluate the safety and effectiveness of the Genous Bio-engineered R stentTM in conjunction with optimal statin therapy (80mg of atorvastatin), in the treatment of elective patients with up to two de novo…
Primary • To investigate the safety and tolerability of long-term treatment with 1.5 mg or 3.0 mg of Org 50081 in elderly outpatients with chronic primary insomnia. Secondary • To collect exploratory efficacy data of long-term treatment with Org…
Does antagonism of the adenosine receptor by caffeine lead to an increased LPS-induced inflammatory reaction and an increase in (subclinical) tissuedamage?Does the C34T-polymorphism of the enzyme AMP-deaminase lead to a decreased inflammatory…
The main objective of this study is to determine if Low-Flow is non inferior in reducing apneic spells compared to caffeine. Secondary objectives are investigating if these treatments have an effect on the need of supplemental ventilation and on the…
Primary objective:To evaluate the effect of AMG 145 administered subcutaneously (SC) once every month (QM) compared with ezetimibe (Part B), on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic…
To investigate the effect of modafinil (200 mg) and caffeine (300 mg) on vigilance in low, medium and high caffeine consumers during the circadian trough in order to determine the best pharmacological agent to target fatigue.
The study will be performed in 3 parts, Parts 1, 2 and 3. In all parts, the purpose is to investigate to what extent APX001 is tolerated. In addition, it will be investigated how quickly and to what extent APX001 is absorbed and eliminated from the…
Primary objective:• To investigate the effect of THB001 on the pharmacokinetics (PK) of caffeine, omeprazole and midazolam.Secondary objective:• To evaluate the safety and tolerability of THB001 co-administered with caffeine, omeprazole and…