Dataset Information

Vericiguat: A Randomized, Phase Ib, Placebo-Controlled, Double-Blind, QTc Interval Study in Patients with Chronic Coronary Syndromes.

ABSTRACT:

Background

Vericiguat is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event.

Objective

To investigate the effects of vericiguat on QT interval in patients with chronic coronary syndromes (CCS).

Methods

This was a randomized, phase Ib, placebo-controlled, double-blind, double-dummy, multicenter study. Vericiguat once daily was up-titrated from 2.5 mg to 5 mg and then to 10 mg (treatments A, B, and C) at 14-day intervals. Positive control was moxifloxacin 400 mg (single dose on day 8 or day 50; placebo on other days [treatment D]). We evaluated the placebo-adjusted change from baseline of the Frederica-corrected QTc interval (QTcF), pharmacokinetics, safety, and tolerability of vericiguat.

Results

In total, 74 patients with CCS, with mean (standard deviation) age 63.4 (8.0) years, were included and 72 patients completed the study. At each timepoint up to 7 h after administration, mean placebo-corrected change in QTcF from baseline was < 6 ms and the upper limit of the two-sided 90% confidence interval of the mean was below the 10-ms threshold for clinical relevance. Moxifloxacin confirmed the assay sensitivity. Median time of maximum concentration of vericiguat was 4.5 h post-dose. The adverse event profile of vericiguat was consistent with its mechanism of action, and the findings did not indicate any safety concerns.

Conclusions

As part of an integrative risk assessment, this study demonstrated no clinically relevant corrected QT prolongation with vericiguat 10 mg once daily at steady state.

Clinical trial registration

ClinicalTrials.gov number, NCT03504982.

SUBMITTER: Bottcher M

PROVIDER: S-EPMC10006255 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Vericiguat: A Randomized, Phase Ib, Placebo-Controlled, Double-Blind, QTc Interval Study in Patients with Chronic Coronary Syndromes.

Böttcher Michael M Düngen Hans-Dirk HD Corcea Vasile V Donath Frank F Fuhr Rainard R Gal Pim P Mikus Gerd G Trenk Dietmar D Coenen Martin M Pires Philippe Vieira PV Maschke Claudia C Aliprantis Antonios Othon AO Besche Nina N Becker Corina C

American journal of cardiovascular drugs : drugs, devices, and other interventions 20230112 2

<h4>Background</h4>Vericiguat is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event.<h4>Objective</h4>To investigate the effects of vericiguat on QT interval in patients with chronic coronary syndromes (CCS).<h4>Methods</h4>This was a randomized, phase Ib, placebo-controlled, double-blind, double-dummy, multicenter study. Vericiguat once daily was up-titrated from 2.5 mg to 5 mg ...[more]

PMID: 36633816

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Dataset Information

Vericiguat: A Randomized, Phase Ib, Placebo-Controlled, Double-Blind, QTc Interval Study in Patients with Chronic Coronary Syndromes.

Background

Objective

Methods

Results

Conclusions

Clinical trial registration

Publications

Vericiguat: A Randomized, Phase Ib, Placebo-Controlled, Double-Blind, QTc Interval Study in Patients with Chronic Coronary Syndromes.

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