Study assessing impact of additional reduction of bad cholesterol on heart related diseases with AMG 145 when used in combination with cholesterol lowering medications
Phase 3
Completed
- Conditions
- Health Condition 1: null- DyslipidemiaHealth Condition 2: I519- Heart disease, unspecified
- Registration Number
- CTRI/2014/01/004324
- Lead Sponsor
- Amgen Technology Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 266
Inclusion Criteria
1. Male or female >= 40 to <= 85 years of age {Note: For India the upper age will be limited to 80yrs as per DCGI approval letter}
2. History of clinically evident cardiovascular disease at high risk for a recurrent event
3. Fasting LDL-C >= 70 mg/dL (>= 1.8 mmol/L) ) or non-HDL-C >= 100 mg/dL ( > 2.6 mmol/L)
4. Fasting triglycerides <= 400 mg/dL (4.5 mmol/L)
Exclusion Criteria
1. NYHA class III or IV, or last known left ventricular ejection fraction less than 30%
2. Uncontrolled hypertension
3. Uncontrolled or recurrent ventricular tachycardia
4. Untreated hyperthyroidism or hypothyroidism
5. Homozygous familial hypercholesterolemia
6. LDL or plasma apheresis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the time to cardiovascular death, myocardial infarction, <br/ ><br>hospitalization for unstable angina, stroke, or coronary revascularization, whichever <br/ ><br>occurs first. (Note: The primary endpoint includes all adjudicated strokes, ischemic and <br/ ><br>hemorrhagic.)Timepoint: The study is event driven and will conclude when at least 1630 subjects have experienced an event adjudicated as qualifying for the key secondary endpoint
- Secondary Outcome Measures
Name Time Method â?¢ time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first <br/ ><br>Other secondary endpoints are: <br/ ><br>â?¢ time to cardiovascular death <br/ ><br>â?¢ time to death by any cause <br/ ><br>â?¢ time to first myocardial infarction <br/ ><br>â?¢ time to first stroke <br/ ><br>â?¢ time to first coronary revascularization <br/ ><br>â?¢ time to cardiovascular death or first hospitalization for worsening heart failure, <br/ ><br>whichever occurs first <br/ ><br>â?¢ time to ischemic fatal or non-fatal stroke or TIA, whichever occurs firstTimepoint: The study is event driven and will conclude when at least 1630 subjects have experienced an event adjudicated as qualifying for the key secondary endpoint