To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by SAR236553 in comparison withezetimibe after 24 weeks of treatment in patients with hypercholesterolemia
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
hypercholesterolemie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percent change in LDL-C after 24 weeks
Secondary outcome
Percent change in LDL-C Percent change after 12 weeks
Percent change in other lipid parameters after 24 weeks
Background summary
A high cholesterol increases the risk of cardiovascular disease. It is
therefore important to treat a high cholesterol. Medicines for this already
exist, but they know side effects and do not always have enough effect. Sanofi
is therefore developing a new drug to lower cholesterol, SAR236553. We will
test this drug in this trial. It may help to lower patient*s cholesterol alone
or in combination with other drugs in the future.
Study objective
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by
SAR236553 in comparison with
ezetimibe after 24 weeks of treatment in patients with hypercholesterolemia
Study design
The EFC11716 study is A Randomized, Double-Blind, Active-Controlled,
Parallel-Group Study
Intervention
Group SAR236553
• SAR236553 by injection every two weeks (75 of 150mg)
• placebo ezetimibe (capsule, orally), once daily.
Group Ezitimibe
• ezetimibe (capsule, orally), once daily
• placebo SAR236553 by injection every two weeks (75 of 150mg)
Study burden and risks
SAR236553
The most common side effects reported in previous completed studies of
SAR236553 in patients who received at least one dose of SAR236553 include:
injection site reactions, dizziness, headache, nausea and diarrhea.
Ezetimibe:
abdominal pain, diarrhea, flatulation and feeling tired
Kampenringweg 45 E
GOUDA 2803PE
NL
Kampenringweg 45 E
GOUDA 2803PE
NL
Listed location countries
Age
Inclusion criteria
Patients with hypercholesterolemia at moderate cardio-vascular (CV) risk defined with a 10-year risk SCORE >=1% and < 5% based on the Systematic Coronary Risk Estimation (SCORE)
Exclusion criteria
* Age < 18 or legal age of adulthood, whichever is greater
* LDL-C < 100 mg/dL (< 2.59 mmol/L) or > 190 mg/dL (> 4.9 mmol/L)
* Fasting serum TG > 400 mg/dL > 4.52 mmol/L)
* Known history of homozygous or heterozygous familial hypercholesterolemia
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-001424-38-NL |
| ClinicalTrials.gov | NCT01644474 |
| CCMO | NL41278.060.12 |