drugset / Trial / NCT03504982
Study to Evaluate the QT / QTc Interval Prolongation Potential of Vericiguat
RandomizedParallel-groupQuadruple-blindBasic science
Summary
The primary objective of this study was to investigate whether there is a clinically meaningful effect on QTc change from baseline relative to placebo after administration of 10 mg at steady state in patients with stable CAD (coronary artery disease).
Timeline
- Start
- 2018-05-17
- Primary completion
- 2018-11-29
- Completion
- 2019-02-26
Outcome
Met primary endpoint
paper mean placebo-corrected change in QTcF from baseline was < 6 ms PMID 36633816 ↗
paper upper limit of the two-sided 90% confidence interval of the mean was below the 10-ms threshold for clinical relevance. PMID 36633816 ↗
paper this study demonstrated no clinically relevant corrected QT prolongation with vericiguat 10 mg once daily at steady state. PMID 36633816 ↗
Publications
- Ruehs H, Solms A, Frei M, Becker C, Trujillo ME, Garmann D, Meyer M. Assessing QTc Effects of Vericiguat Using Two Different Concentration-QTc Modeling Approaches. Clin Pharmacokinet. 2023 Nov;62(11):1639-1648. doi: 10.1007/s40262-023-01282-y. Epub 2023 Sep 6.
- Bottcher M, Dungen HD, Corcea V, Donath F, Fuhr R, Gal P, Mikus G, Trenk D, Coenen M, Pires PV, Maschke C, Aliprantis AO, Besche N, Becker C. Vericiguat: A Randomized, Phase Ib, Placebo-Controlled, Double-Blind, QTc Interval Study in Patients with Chronic Coronary Syndromes. Am J Cardiovasc Drugs. 2023 Mar;23(2):145-155. doi: 10.1007/s40256-022-00557-2. Epub 2023 Jan 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Moxifloxacin | Small molecule | 400 mg | — |
| Subject | Vericiguat | Other / unclassified | 2.5 mg | — |
| Subject | Vericiguat | Other / unclassified | 5 mg | — |
| Subject | Vericiguat | Other / unclassified | 10 mg | — |