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NCT03626662 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
A Phase 1 study of Cardiovascular Disease, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
- 9
- Study locations
NCT03626662: Completed Phase 1 study of Cardiovascular Disease, sponsored by Amgen.
NCT03626662 is a Phase 1 study of Cardiovascular Disease that has completed, run by Amgen. The registered enrollment target is 79 participants, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (97% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03626662, a Phase 1 study of Cardiovascular Disease, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in subjects with elevated plasma Lipoprotein(a) \[Lp(a)\]. AMG 890 will be evaluated in approximately 80 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
Primary Outcome
An adverse event was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as any event with onset after the administration of the first dose of investigational product and up to and including the end of treatment date, or end of trial for participants who discontinued the trial during the treatment period. Clinically significant changes in vital signs, electrocardiograms (ECGs), and safety laboratory analytes were included as TEAEs.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AMG 890
Study Locations (9)
Florida
- Excel Medical Clinical Trials - Boca Raton
- Jacksonville Center for Clinical Research - Jacksonville
- QPS Miami Research Associates - South Miami
California
- Orange County Research Center - Tustin
Kansas
- University of Kansas Medical Center - Kansas City
New York
- New York University - New York
Ohio
- Medpace Inc - Cincinnati
South Australia
- Clinical Medical and Analytical eXellence CMAX - Adelaide
Western Australia
- Linear Clinical Research Limited - Nedlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2018-07-30 |
| Est. Completion | 2023-04-18 |
| Phase | Phase 1 |
What the finished NCT03626662 record still lists
NCT03626662 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03626662 lists 9 locations in 7 states (Florida, California, Kansas).
Frequently Asked Questions
What is clinical trial NCT03626662 about?
NCT03626662 is a clinical study titled "Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)". This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in subjects with elevated plasma Lipoprotein(a) \[Lp(a)\]. AMG 890 will be evaluated in approximately 80 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
What is the current status of trial NCT03626662?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2018-07-30. Estimated completion is 2023-04-18.
What conditions does trial NCT03626662 study?
This clinical trial studies the following conditions: Cardiovascular Disease.
What interventions are being tested in trial NCT03626662?
The interventions under investigation include: Placebo (DRUG), AMG 890 (DRUG).
Who is sponsoring clinical trial NCT03626662?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03626662 being conducted?
This trial has 9 study locations across California, Florida, Kansas, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cardiovascular Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03626662's enrollment target sits among peer trials
79 87th of 137 higher than 51 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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