To characterize the safety and tolerability of long-term administration of evolocumab in subjects with known coronary artery disease andhypercholesterolemia.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Subject incidence of adverse events
Secondary outcome
LDL-C
Background summary
Cardiovascular disease (CVD) remains the most important healthcare issue in the
developed world and is rapidly becoming so in large parts of the developing
world. Despite the availability of several classes of very effective drugs,
dyslipidemia and risk factor control are poorly served and there remains a
large unmet medical need for new, effective and well tolerated therapies.
AMG 145 (evolocumab) is a fully human monoclonal immunoglobulin (Ig) G2 that
binds specifically to human PCSK9 and prevents the interaction of PCSK9 with
LDLR. Details of the biochemistry, nonclinical pharmacology, nonclinical
pharmacokinetics (PK), nonclinical toxicology , and data from five P2 and six
P3 clinical trials are contained in the Investigator*s Brochure, 2013.
Over the course of the last three decades, considerable technological advances
in arterial imaging have permitted visualization of the full extent of
atherosclerotic plaque. Intravascular ultrasound (IVUS) used in the parent
trial (study 20120153) involves the placement of high frequency ultrasound
transducers within the coronary artery lumen, generating high resolution
imaging of the full thickness of the artery wall. In general
IVUS clinical trials have demonstrated disease progression, in direct
association with LDL-C levels. Study 20140128 is a global phase 3 study that
will provide long-term safety and efficacy data for evolocumab in a high risk
subject population with known coronary artery disease receiving evolocumab in
combination with statin and other background lipid lowering therapy. Patients
that successfully complete parent study 20120153 will be eligible to
participate in this 2 year trial.
Study objective
To characterize the safety and tolerability of long-term administration of
evolocumab in subjects with known coronary artery disease and
hypercholesterolemia.
Study design
This is a multicenter, open-label extension study to assess the long-term
safety and efficacy of evolocumab.
The overall study design is described by a study schema at the end of the
protocol synopsis section.
The study endpoints are defined in Section 10.1.
Study burden and risks
See E9
Minervum 7061
Breda 4817ZK
NL
Minervum 7061
Breda 4817ZK
NL
Listed location countries
Age
Inclusion criteria
Subjects will be eligible for the study if they completed study 20120153.
Exclusion criteria
- Did not complete IP in the parent study 20120153;- Have an unstable medical condition, in the judgment of the investigator;- Known sensitivity to any of the products to be administered during dosing;- Currently enrolled in another investigational device or drug study (excluding evolocumab parent study), or less than 30 days since ending another;- investigational device or drug study(s),or receiving other investigational agent(s)
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 | EUCTR2014-001524-30-NL |
| ClinicalTrials.gov | NCTnummernognietbekend.Hetnummervolgt. |
| CCMO | NL50994.060.14 |