A Phase 3 extension study of MK-0616 in Adults with Hypercholesterolaemia
Research type
Research Study
Full title
A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia
IRAS ID
1009482
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
Research summary
Researchers want to learn about the long-term safety and effects of a trial medicine designed to lower low-density lipoprotein cholesterol (LDL-C). LDL-C is sometimes called “bad cholesterol.” Cholesterol is a type of fat in a person’s blood. Having too much LDL-C can cause fatty deposits (called plaque) to stick to the walls of blood vessels. This causes blood vessels to narrow, which means less blood can flow through them. Lowering a person’s LDL-C can lower their chances of events such as heart attacks, stroke, and death.
MK-0616, the trial medicine, is in a group of medicines that have been shown to lower the amount of LDL-C in the blood. This is an extension trial, which means people who were in certain other MK-0616 studies (called parent studies) may be able to join.
The goal of this trial is to learn about the long-term safety of MK-0616 in people with high cholesterol and how well they tolerate it.
About 3000 people with high cholesterol will be in this trial. They will be at least 18 years old and:
•Completed a parent trial of MK-0616
•Took treatment during the parent trial as directed
•Were still on treatment at the end of the parent trial
Everyone in the trial will take MK-0616 by mouth as a tablet once a day. They will take MK-0616 on an empty stomach and must not eat or drink anything, except small amounts of water, for 8hours before and 30minutes after taking MK-0616.
Both the people in the trial and the researchers will know which trial treatment a person is getting because everyone will take MK-0616 (open-label trial). During the trial, people may have blood and urine tests, and physical examinations.
A person may be in this trial and take MK0616 for up to 3 years, depending on when they start this extension trial.
Clinical studies may have benefits and risks. People may benefit because the trial medicine may lower LDL-C or stop it from getting worse. There may be risks because the trial medicine may not work or may cause health problems.REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0479
Date of REC Opinion
3 Sep 2024
REC opinion
Further Information Favourable Opinion