Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
- Conditions
- Cardiovascular Disease
- Registration Number
- JPRN-jRCT2031200367
- Lead Sponsor
- ocal Contact
- Brief Summary
Statistically significant decreases in % change from baseline in Lp(a) at week 36 and 48 relative to placebo were observed for all olpasiran dose groups. Significant decreases in % change from baseline in LDL-C and ApoB at week 36 and 48 relative to placebo were observed for all olpasiran dose groups. Olpasiran was shown to be safe and well tolerated during the treatment period and the extended safety follow-up period. Most AEs were mild. 1 fatal event of pneumonia was reported in the placebo group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 281
Age 18 to 80 years
- Lipoprotein (a) > 150 nmol/L
- Evidence of atherosclerotic cardiovascular disease
- Severe renal dysfunction
- History or clinical evidence of hepatic dysfunction
- Malignancy within the last 5 years
- Currently receiving, or less than 3 months at Day 1 since receiving > 200 mg/day Niacin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36 [ Time Frame: Baseline and Week 36 ]<br>Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
- Secondary Outcome Measures
Name Time Method