NIPH Clinical Trials Search

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

Registered date:19/02/2021

Randomized Study to Evaluate Efficacy, Safety, and Tolerability of AMG 890 in Subjects With Elevated Lipoprotein(a)

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedCardiovascular Disease
Date of first enrollment28/07/2020
Target sample size240
Countries of recruitmentAustralia,Canada,Iceland,United States,Japan
Study typeInterventional
Intervention(s)- Drug: AMG 890 Dose 1 Dose 2 Dose 3 Dose 4 - Drug: Placebo Dose 5

Outcome(s)

Primary Outcome1. Percent change in Lp(a) [ Time Frame: Baseline and week 36 ]
Secondary Outcome1. Percentage change from baseline in Lp(a) [ Time Frame: Baseline and week 48 ] 2. Percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline and Weeks 36 and 48 ] 3. Percentage change in Apolipoprotein(B) (ApoB) [ Time Frame: Baseline and weeks 36 and 48 ] 4. Maximum observed concentration (Cmax) of AMG 890 [ Time Frame: 48 weeks ] 5. Area under the concentration-time curve (AUC) [ Time Frame: 48 weeks ]

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- Moderate to severe renal dysfunction - History or clinical evidence of hepatic dysfunction - Malignancy within the last 5 years

Related Information

Contact

Public contact
Name Local Contact
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 Local Contact
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.