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NCT03456856 · ClinicalTrials.gov registry record · Phase 4
A Study of Ivabradine in African-American/ Black Subjects With Heart Failure and Left Ventricular Systolic Dysfunction.
A Phase 4 study of Heart Failure (HF), sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT03456856: Completed Phase 4 study of Heart Failure (HF), sponsored by Amgen.
NCT03456856 is a Phase 4 study of Heart Failure (HF) that has completed, run by Amgen. The registered enrollment target is 30 participants, below the 168-participant average among 3 other Heart Failure (HF) trials with a reported enrollment target (82% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03456856, a Phase 4 study of Heart Failure (HF), has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study is a prospective, open-label, single-arm intervention study in African-American/Black subjects with heart failure and reduced ejection fraction (HFrEF). There will be a 7-day screening period, a 57-day open-label treatment period, and a safety follow-up at day 87 or 30 days after the last administration of the investigational product.
Primary Outcome
Summary is based on observed data, and no imputation is used for missing values. Least-square mean is from the repeated measures model which includes scheduled visits and baseline HR measurement as covariates. The mean change from baseline in heart rate is compared to -5 beats/min which is observed in the placebo group in the Systolic Heart Failure Treatment with the IF Inhibitor Ivabradine Trial (SHIFT) study ( NCT02441218, PMID 20801500).
Conditions Studied
Interventions
- DRUG Ivabradine
Study Locations (3)
Delaware
- Research Site - Wilmington
Michigan
- Research Site - Detroit
New York
- Research Site - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-09-28 |
| Est. Completion | 2019-05-20 |
| Phase | Phase 4 |
What the finished NCT03456856 record still lists
NCT03456856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 168-participant average among 3 other Heart Failure (HF) trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Heart Failure (HF) appearing as the primary indexed condition, and to 1 intervention - of which Ivabradine is the first listed.
NCT03456856 reports a single indexed study location in Delaware, Michigan, New York.
Frequently Asked Questions
What is clinical trial NCT03456856 about?
NCT03456856 is a clinical study titled "A Study of Ivabradine in African-American/ Black Subjects With Heart Failure and Left Ventricular Systolic Dysfunction.". This study is a prospective, open-label, single-arm intervention study in African-American/Black subjects with heart failure and reduced ejection fraction (HFrEF). There will be a 7-day screening period, a 57-day open-label treatment period, and a safety follow-up at day 87 or 30 days after the las...
What is the current status of trial NCT03456856?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2017-09-28. Estimated completion is 2019-05-20.
What conditions does trial NCT03456856 study?
This clinical trial studies the following conditions: Heart Failure (HF).
What interventions are being tested in trial NCT03456856?
The interventions under investigation include: Ivabradine (DRUG).
Who is sponsoring clinical trial NCT03456856?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03456856 being conducted?
This trial has 3 study locations across Delaware, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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