CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Ivabradinedrug
Likely dose
Ivabradine 5.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03456856
NCT03456856Phase 4Completed

Open-label, Single-arm, Study Assessing the Efficacy and Safety of Ivabradine (Corlanor) in African-American/Black Subjects With Heart Failure and Left Ventricular Systolic Dysfunction

Amgen·interventional·Posted Mar 7, 2018·Updated Oct 28, 2021

In Brief

A Phase 4 clinical trial evaluating Ivabradine for Heart Failure (HF). Completed, enrolled 30 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 7, 2018
Enrollment StartSep 28, 2017
Primary CompletionApr 19, 2019
Study CompletionMay 20, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.3 years ago

Interventions

Ivabradinedrug

Film-coated tablets taken orally with food twice a day. Tablets supplied in strengths of 5.0 mg and 7.5 mg. 5.0 tablets were split into equal halves for dosages of 2.5 mg.