A Phase 3 multi-centre study to test the efficacy, safety and tolerability of PF-04950615 administered subcutaneously in reducing the occurrence ofmajor cardiovascular events due to clogging up of arteries by fatty substances in high risk subjects.
- Conditions
- atherosclerosisMedDRA version: 18.1Level: LLTClassification code 10003601Term: AtherosclerosisSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-002795-41-SK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 9000
1. Informed Consent
There must be evidence of personally signed and dated informed consent
documents for both the pre-screening and screening visits, indicating
that the subject (or a legal representative) has been informed of all pertinent aspects of the study. The pre-screening visit informed consent
form will be limited to study activities up until the screening visit. The
screening visit informed consent form will cover all aspects of the study.
2. Compliance
Subjects must be willing and able to comply with scheduled visits,
treatment plan, laboratory tests, and other study procedures.
3. Age
For subjects who have had a prior CVD event, or who have a condition of
elevated LDL-C without a prior CVD event (heterozygous familial
hypercholesterolemia [heFH] or an LDL-C=190 mg/dL [4.9 mmol/L]),
subjects must be men or women age= the legal age of majority (legal
adulthood), in the subject's country. For other subjects who have not
had a prior CVD event, men must be age =50 years and women must be
age=60 years.
4. Acceptance of administration of investigational product
Subjects must be willing and able to self-administer or be administered
sub-cutaneous injections of investigational product.
5. Requirements for background lipid lowering treatment
There should be no plans at the time of screening and randomization to
modify the dose of statin for the duration of the trial. Unless the
background lipid lowering treatment exceptions described below are
met, subjects must be treated with one of the following highly effective
statins at the specified daily doses for =6 weeks prior to the screening
visit:
-atorvastatin, 40 or 80 milligrams (mg) once a day;
- rosuvastatin, 20 or 40 mg, once a day;
- simvastatin 40 mg, once a day or, if a subject has been on that dose for
>1 year, 80 mg, once a day.
Combination medications that contain atorvastatin, rosuvastatin, or
simvastatin components described at the aforementioned doses will be
permitted. Background lipid lowering treatment exceptions
The following background lipid lowering treatment exceptions are
permitted:
-Lower doses of statins due to partial statin intolerance
Subjects may be on a lower dose of one of the highly effective statins
described above if there is documented intolerance to any one of them
(atorvastatin, rosuvastatin, or simvastatin) at the aforementioned doses.
Intolerance to any dose of any statin must be documented as historical
adverse events attributed to the statin in question, in the source
documentation and case report form (CRF).
- Regulatory limitations
Subjects may be on a lower dose of one of the highly effective statins
described above if the highest locally approved dose for one of the
stated statins is lower than those doses shown above (eg, in Japan,
atorvastatin 20 mg, once a day, is the highest locally approved dose).
- Alternative statins
Subjects may be treated with other statins (pravastatin, fluvastatin,
pitavastatin, or lovastatin), different from the highly effective statins
listed above, if there is documented intolerance to any two different
highly effective statins (atorvastatin, rosuvastatin, simvastatin) at the
lowest available daily dose for at least one of those highly effective
statins. Intolerance to any statin must be documented as historical
adverse events attributed to the statin in question, in the source
documentation and CRF.
-No background statin therapy
Subjects may be enrolled w
1. Personnel involved in the conduct of the study
Subjects who are investigational site staff members directly involved in
the conduct of the trial and their family members, site staff members
otherwise supervised by the Investigator, or subjects who are Pfizer
employees directly involved in the conduct of the trial.
2. Exclusionary prior CV events or planned revascularization procedures
-A planned coronary (PCI or CABG) or other arterial revascularization;
-Myocardial infarction, stroke, or any non-coronary arterial
revascularization= 30 days prior to screening;
-PCI= 90 days prior to screening.
3. Participation in prior clinical research studies
Participation in other studies involving small molecule investigational
drug(s) (Phases 1-4) within 1 month, or five half-lives, of Visit 1,
whichever is longer; any
participation in a cholesteryl ester transfer protein (CETP) inhibitor trial
for any length of time; or any biological agents within 6 months or 5
half-lives, of Visit 1, whichever is longer (the investigator should refer to
documents provided by the subject on the other study to determine the
investigational product half-life). If the blind of the prior study has been
broken and the investigator provides documentation that the subject
received placebo, the potential subject can be included, regardless of
when participation occurred.
4. Other exclusionary conditions
Other severe, acute, or chronic medical or psychiatric condition or
laboratory abnormality that may increase the risk associated with study
participation or investigational product administration or may interfere
with the interpretation of study results and, in the judgment of the
investigator, would make the subject inappropriate for entry into this
study.
5. Childbearing potential and/or breast feeding
Pregnant females; breastfeeding females; males and females of
childbearing potential who are unwilling or unable to use a highly
effective method of contraception as outlined in this protocol for the
duration of the study and for 63 days after last dose of investigational
product
6. Latex sensitivity
Latex sensitive individuals (due to potential for exposure to natural dry
rubber in the prefilled syringe cap of investigational product, during
administration).
7. Apheresis
Undergoing lipid apheresis, within 6 weeks of screening, or planned start
of lipid apheresis.
8. Severe congestive heart failure
Congestive heart failure of New York Heart Association (NYHA) Class IV,
or if there is prior documentation of left ventricular ejection fraction
(LVEF) of <25%, measured by imaging.
9. Dialysis
Potential subjects with end stage renal disease on dialysis.
10. Chronic renal insufficiency
Potential subjects with an eGFR of <30 ml/min/1.73m2 by MDRD
formula at Visit 1.11. Hypertension
Poorly controlled hypertension at any screening visit or at
randomization, defined as the average of two systolic blood pressure
(BP) measurements >180 mmHg or the average of two diastolic BP
measurements >110 mmHg even with treatment. Subjects who have
hypertension and are controlled on stable doses of anti-hypertensive
medications may be included. An additional set of BP measurements may
be performed within the hour or at the completion of the office visit, to
determine if a subject may be included in the study, given the potential
for white coat hypertension. The final set of measurements will be the
measurements of record.
12. Cer
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method