NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031200367

Registered date:19/02/2021

Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedCardiovascular Disease
Date of first enrollment28/07/2020
Target sample size240
Countries of recruitmentAustralia,Japan,Canada,Japan,Iceland,Japan,United States,Japan,Denmark,Japan,Netherlands,Japan
Study typeInterventional
Intervention(s)- Drug: olpasiran Dose 1 Dose 2 Dose 3 Dose 4 - Drug: Placebo Dose 5

Outcome(s)

Primary Outcome1. Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36 [ Time Frame: Baseline and Week 36 ] 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 Outcome1. Percentage Change From Baseline in Lp(a) at Week 48 [ Time Frame: Baseline and Week 48 ] 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. 2. Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48 [ Time Frame: Baseline; Week 36 and Week 48 ] 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. 3. Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48 [ Time Frame: Baseline; Week 36 and Week 48 ] 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. 4. Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48 [ Time Frame: Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48 ] Pharmacokinetic blood draws were collected at one timepoint during the 6-12 and 24-72 hour flexible time windows and at Week 48. Lower limit of quantification (LLOQ) = 0.400 ng/mL. Values below the LLOQ were set to zero.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 80age old
GenderBoth
Include criteria- Age 18 to 80 years - Lipoprotein (a) > 150 nmol/L - Evidence of atherosclerotic cardiovascular disease
Exclude criteria- 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

Related Information

Contact

Public contact
Name Contact Local
Address Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo Tokyo Japan 107-6239
Telephone +81-80-7217-8592
E-mail clinicaltrials_japan@amgen.com
Affiliation Amgen K.K.
Scientific contact
Name Contact Local
Address Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo Tokyo Japan 107-6239
Telephone +81-80-7217-8592
E-mail clinicaltrials_japan@amgen.com
Affiliation Amgen K.K.