Group 1
- 24 March up to and including 3 April
Period(s) of stay (11 days)
- 24 March up to and including 3 April
- 10 April
Visit(s)
- 10 April
- 24 April
Follow-up
- 24 April
- €2960,- to €3189,-
Compensation
- €2960,- to €3189,-
Find out if you qualify for this trial
- You are a healthy male or female
- You are between 50 and 79 years old
- You weigh between 60 and 120 kg
- Your Body Mass Index (BMI) is between 18 and 30 kg/m2
- Non-smoker
Good to know about this trial
- This research has a relatively short residence period
- The research drug or placebo is administered only 1 time during the study
- The investigational drug has previously been studied and administered to humans
Study groups
Register without obligation for the group of your preference
The research physician about this research
Additional information
This clinical trial will research a possible new treatment that can counter the effects of medications called direct acting oral anticoagulants. These anticoagulants inhibit the formation of blood clots and reduce the chance of a blood vessel blockage which is important in some people who are prone to this kind of problem but because they reduce the ability of their blood to clot this can be a problem if they experience a bleed or need surgery urgently. This treatment is meant for patients using anticoagulants to restore the coagulation (blood clotting) when they are experiencing bleeding or need urgent surgery.
Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können.
Who can participate?
Target group
- You are a healthy male or female
- You are between 50 and 79 years old
- You weigh a minimum of 60 kg and a maximum of 120 kg
- You have a Body Mass Index (BMI) of minimum 18.0 and maximum 30.0 kg/m2.
- You have not smoked in the past 3 months.
Note:
- You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the follow-up visit of the previous study).
- You cannot participate in the trail if you have participated in the clinical trial CS0372 at QPS, as you are not allowed to have previously received this drug.
- To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.
WHAT IS THE COMPENSATION FOR THIS RESEARCH?
Compensation
You will receive a gross compensation of € 2.960,- for participation in part 1.
Travelling expenses will be reimbursed based on the distance traveled (€ 0,19 net per kilometer) with a minimum of € 12,- and a maximum of € 160,- (840 kilometers) per round trip, regardless of the mode of transportation.
HOW LONG DOES THIS RESEARCH TAKE?
Period of stay and research
Part 2 of the study consists of a clinic period of 11 days (10 nights). You will then return to the clinic for another outpatient visit about a week after you leave.
If needed, you might be asked back for 1 extra follow-up visit approximately 1 month after your final visit. You will receive extra compensation for this visit as it is not part of the standard participation
Frequently asked questions
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You can participate in a trial a maximum of four times a year. There must be at least 30 days between two trials. Some trials have a longer waiting period.
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During the trial, you may suffer from mild symptoms like headache or nausea. That may be caused by the medication. It might also be caused by needing to fast for the trial, for example. Those side effects are no fun, but fortunately are not dangerous.
Before a medication is tested on people, it has already been studied extensively in a lab. This enables us to predict well which side effects you might get and we can prepare you for them. It almost never happens that participants suffer from unexpected side effects. For example, an allergic reaction to the medication occurs on average once a year.
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Your participation in a clinical trial is always voluntary. You can therefore decide to stop at any time. Sometimes you have to stop. For example because of family circumstances or if the doctor decides it is better for your health. If you stop, we will look at what portion of the compensation you are entitled to. It's only fair!
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Als je meedoet aan een onderzoek waarvoor je langer dan 10 dagen in het onderzoekscentrum verblijft, is het soms mogelijk om (in overleg) bezoek te ontvangen.