I need to decide if to be part of a drug trial for a particular drug that should improve cholesterol levels, it is a UK RECOGNISED AND REGISTERED TRIAL, and in the long run may not help me so much, but future patients. Is any one else out there on a similar trial and what are their thoughts on it?
Has any one been on a clinical drug tr... - Cholesterol Support
Has any one been on a clinical drug trial for high cholesterol?
I have been on a trial for something else in the past so would be fully behind your decision, if you go ahead. If new drugs cannot be tested on human "guinea pigs", then how can the proved to be effective with no detrimental side effects?
If they need another volunteer, I would be willing.
Yes and the only one running at the minute is REVEAL.have been on it since Oct,2012.No problems but its maddening not seeing the results of the blood test they take.
Thanks for reply, this is the same trial I have been asked to join, to the best of my knowledge this will go on for some years, how often do you have to attend the clinic.
With regard to blood results, do you still need bloods done with the GP so that he knows your cholesterol levels as well?
Many thanks.
Hi sasan,The first two times three times its 3 monthly and then extends to 6 monthly.The trial is for 5 years and yes your G.P will still do his own thing as the test results do not go to your Doctor. I would suggest you check it out online or give them a ring on 0800-585323 hope this helps. Regards
Could you tell us a bit about REVEAL or aren't you allowed!
I have read that the people who run drug trials are often "quite picky" about who they select and a lot of people who want to participate don't get to be chosen.
I was actually contacted by mail initially, I think,that as I am under a Hospital Lipid CLinic, the Biochemical Department it comes under, sorts out patient data and find those that are suitable for trials., and forwards this information to UK Clinical Trials Unit, (GP's possibly do the same thing.)
In trials, there are obviously stricked guidlines follow, and patients have to fit into catagories to be eligible, being treated for high cholesterol is one, also having a known heart problem or vascular disease. Then there are other conditions which would make patients unelligable, You can google 'Reveal', and you should find it, or access Clinical Trials UK, to find out the patient criteria for this trial. It is in its 3rd stage, and started in USA, now is covering Europe, in England I believe it's based in Oxford, but patients can be from any parts of the country where hospitals are participating.
I have to admit that these trials are rarely advertised outside the hospital environment , possibly due to patients clinical information being needed to ascertain the suitability.
Look it up, you may find a lot more information on this and other trials, if interested speak to your GP in the first instance, hope this is of some help.
Strangely I was asked to the Reveal trial but was refused because my cholesterol was too high and due to FH would probably not be reduced
Thanks for your really interesting reply Sasan, I've often wondered how patients got recruited! I'm just interested in drug trials in general.
I have looked it up and it's a trial to see whether anacetrapid 100mg plus atorvastatin 20mg is better than atorvastatin alone in preventing major cardio vascular events.
You, of course don't know whether you're taking the placebo or the real drug ,(anacetrapid that is) but you're doing a fantastic job taking part.
I would be doubly excluded as I can't tolerate statins and I don't have established vascular disease !
I started on the Reveal trial in July 2012. I received a letter which said that my GP had recommended me. Apparently I ticked a few boxes since I am a diabetic on insulin, had a bypass 4 years ago and was on Statins already (Simvastatin). When I agreed to participate I was switched from Simvastatin to Atorvastatin. You then started to take an additional pill that is being trialled which enhances you good cholesterol and reduce the bad.
When I have attended the now three monthly visits I am told my cholesterol levels and a liver function test that they do (before I started the trial I was getting a high ALT reading which has now reduced to normal).
Mine is conducted at an NHS hospital in Surrey and it is controlled from Oxford University.
This one is NHS Sponsored and there is no pay for it other than expenses. The time involved is just under an hour every three months and is likely to last about 4 years I was told.
Regards
David
I have just completed a trial at my hospital. It was for an American pharma company and was a latter stage trial. I would not consider an early stage trial as the risks are unknown!
This was a blind trial involving two drugs and a fortnightly injection. Either placebo or real. It was simple to do and the hospital looked after me very well. Should the product come to market it will be very useful for inherited high cholesterol. Just go with your instincts on this one, ask questions and make up your mind from there. Hope this helps!