Evidence map›Paper›PMID 30447156›Full record

Trial reportClinical pharmacology and therapeutics2019

Assessment of Multi-Ion Channel Block in a Phase I Randomized Study Design: Results of the CiPA Phase I ECG Biomarker Validation Study.

Jose Vicente, Robbert Zusterzeel, Lars Johannesen, Roberto Ochoa-Jimenez, Jay W Mason, Carlos Sanabria, Sarah Kemp, Philip T Sager, Vikram Patel, Murali K Matta and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03070470 (Comprehensive in Vitro Proarrhythmia Assay), which is not on this map. Cited by 50 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03070470 phase1completednot on this map

Comprehensive in Vitro Proarrhythmia Assay (CiPA) Clinical Phase 1 ECG Biomarker Validation Study (CiPA Phase 1 ECG Biomarker Study)

TypeinterventionalSponsorFood and Drug Administration (FDA)Ran2017 to 2017Enrolled60ConditionsDrug-induced QT Prolongation, Pharmacokinetics, PharmacodynamicsArmsRanolazine, Verapamil, Lopinavir / Ritonavir, Chloroquine, Placebo
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Jose VicenteOffice of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Robbert ZusterzeelOffice of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Lars JohannesenOffice of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Roberto Ochoa-JimenezOffice of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Jay W MasonDepartment of Medicine, Division of Cardiology, University of Utah, Salt Lake City, Utah, USA.
Carlos SanabriaSpaulding Clinical Research, West Bend, Wisconsin, USA.
Sarah KempSpaulding Clinical Research, West Bend, Wisconsin, USA.
Philip T SagerStanford University, Palo Alto, California, USA.
Vikram PatelOffice of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Murali K MattaOffice of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Jiang LiuOffice of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Jeffry FlorianOffice of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Christine GarnettOffice of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Norman StockbridgeOffice of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
David G StraussOffice of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Balanced multi-ion channel-blocking drugs have low torsade risk because they block inward currents. The Comprehensive In Vitro Proarrhythmia Assay (CiPA) initiative proposes to use an in silico cardiomyocyte model to determine the presence of balanced block, and absence of heart rate corrected J-T

Indexed as

AdultBiomarkersCross-Over StudiesElectrocardiographyFemaleHeart RateHumansIon ChannelsLong QT SyndromeMaleMembrane Transport ModulatorsMyocytes, CardiacPharmaceutical PreparationsTorsades de PointesBiomarkersIon ChannelsMembrane Transport ModulatorsPharmaceutical Preparations

Identifiers

PMID30447156
PMCPMC6654598

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.