ong-term safety and tolerability of REGN727 / SAR236553 in high cardiovascular risk patients with hypercholesterolemia not adequately controlled with their lipid modifying therapy: a randomized, double-blind, placebo-controlled study (LTS11717)
- Conditions
- hypercholesterolemiecholesterol elevationhypercholesteriolemia
- Registration Number
- NL-OMON39801
- Lead Sponsor
- Covance
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 145
Either A or B below and who are not adequately controlled with their lipid modifying therapy: A) Patients with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents
OR
B) Patients with hypercholesterolemia together with established CHD or CHD risk equivalents.
See protocol for more details
* Age < 18 years.
* LDL-C <1.81 mmol/L.
* Statin that is not simvastatin, atorvastatin, or rusovastatin
* simvastatin, atorvastatin, or rusovastatin is not taken dialy or not taken at a registered dose.
* Daily doses above atorvastatin 80 mg, rosuvastatin 40 mg or simvastatin 40 mg (except for patients on simvastatin 80 mg for more than one year, who are eligible).
* Fasting serum TG >4.52 mmol/L)
* Use of fibrates other than fenofibrate within 6 weeks
* Known history of active optic nerve disease
* Pregnancy, inadequate anticonception, breast feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percent change from baseline in LDL-C at week 24. Adverse events.</p><br>
- Secondary Outcome Measures
Name Time Method <p>E.g. % change from baseline in LDL-C at week 12, % patienst meeting the target<br /><br>LDL-C value bereikt in week 24, development of antibodies, PK parameters.</p><br>