Trial · NCT03070470

CiPA Phase 1 ECG Biomarker Validation Study

NCT03070470, Phase 1, Completed, Food and Drug Administration (FDA); results first posted 2020-01-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. CiPA Phase 1 ECG Biomarker Validation Study. Trials, record NCT03070470. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03070470

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: CiPA Phase 1 ECG Biomarker Validation Study
NCT number: NCT03070470
Status: Completed
Phases: Phase 1
Enrollment: 60 participants, actual
Lead sponsor: Food and Drug Administration (FDA)
Conditions: Drug-induced QT Prolongation, Pharmacokinetics, Pharmacodynamics
Interventions: Ranolazine, Verapamil, Lopinavir / Ritonavir, Chloroquine, Placebo, Dofetilide and Diltiazem
First posted: 2017-03-03
Last updated: 2020-01-18
Results first posted: 2020-01-18

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline J-Tpeakc With "Balanced Ion Channel" Drugs (Ranolazine, Verapamil, Lopinavir / Ritonavir)	3 days	The primary outcome measure for the "balanced ion channel" drugs (ranolazine, verapamil, lopinavir / ritonavir) is for the upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model. Placebo drug concentration was set to 0 (see SAP).
Primary	Change From Baseline QTc With "Predominant hERG" Blocking Drug (Chloroquine)	3 days	The primary outcome measure for the "predominant hERG" drug (chloroquine) is for the upper bound of the 2-sided 90% CI to be ≥10 msec for the projected placebo-corrected change from baseline QTc effect at the peak plasma level on Day 1 using a linear mixed-effects exposure response model
Primary	QTc Shortening From Calcium Block (Diltiazem) in the Presence of hERG Block (Dofetilide)	3 days	* It will be assessed whether the projected QTc effect of dofetilide alone is significantly greater (i.e., p\<0.05) than the projected QTc effect of the combination of dofetilide + diltiazem. This will be assessed at the dofetilide peak plasma level on Day 3 (computed from the combination of dofetilide + diltiazem) on the pooled dofetilide alone, diltiazem alone, and dofetilide + diltiazem data using a linear mixed effects model. * Subsequently, and if the test is significant for QTc, the same test will be performed to assess calcium block (diltiazem) effects on J-Tpeakc.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline J-Tpeakc With Balanced Ion Channel Drugs (Ranolazine, Verapamil, Lopinavir / Ritonavir)	3 days	Placebo data was used in the statistical analysis to account for placebo effect. Chloroquine, and dofetilide and diltiazem data were collected but not part of the primary J-Tpeakc analysis. The underlying raw data (available at https://doi.org/10.13026/C2967M) were the input in the statistical analysis. Summary included per PRS review team request.	ms	MEDIAN
PRIMARY	Change From Baseline QTc With Predominant hERG Blocking Drug (Chloroquine)	3 days	Ranolazine, verapamil, lopinavir/ritonavir, and dofetilide and diltiazem data were collected but not part of the primary QTc analysis. The underlying raw data (available at https://doi.org/10.13026/C2967M) were the input in the statistical analysis. Median and range summary included per PRS review team request.	ms	MEDIAN
PRIMARY	QTc Shortening From Calcium Block (Diltiazem) in the Presence of hERG Block (Dofetilide)	3 days	QTc, J-Tpeakc, and drug concentration data from all subjects in the dofetilide and diltiazem arm. Ranolazine, verapamil, lopinavir/ritonavir, chloroquine, and placebo data were collected but not part of this analysis (see SAP). The underlying raw data were the input in the statistical analysis. Summary included per PRS review team request.	ms	MEDIAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline J-Tpeakc With Balanced Ion Channel Drugs (Ranolazine, Verapamil, Lopinavir / Ritonavir)	Ranolazine	-8.3	Full Range -66.4 to 23.6	ms
Change From Baseline J-Tpeakc With Balanced Ion Channel Drugs (Ranolazine, Verapamil, Lopinavir / Ritonavir)	Verapamil	-7.8	Full Range -58.1 to 11.4	ms
Change From Baseline J-Tpeakc With Balanced Ion Channel Drugs (Ranolazine, Verapamil, Lopinavir / Ritonavir)	Lopinavir / Ritonavir	-11.5	Full Range -50.7 to 47.4	ms
Change From Baseline J-Tpeakc With Balanced Ion Channel Drugs (Ranolazine, Verapamil, Lopinavir / Ritonavir)	Placebo	-10.9	Full Range -81.2 to 14.7	ms
Change From Baseline QTc With Predominant hERG Blocking Drug (Chloroquine)	Chloroquine	17.7	Full Range -24.3 to 71.9	ms
Change From Baseline QTc With Predominant hERG Blocking Drug (Chloroquine)	Placebo	-9.3	Full Range -48.3 to 27.6	ms
QTc Shortening From Calcium Block (Diltiazem) in the Presence of hERG Block (Dofetilide)	Dofetilide	2.2	Full Range -35.2 to 64.5	ms
QTc Shortening From Calcium Block (Diltiazem) in the Presence of hERG Block (Dofetilide)	Diltiazem+Dofetilide	-1.7	Full Range -31.9 to 53.6	ms

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ranolazine	10
Overall Study	STARTED	Verapamil	10
Overall Study	STARTED	Lopinavir / Ritonavir	10
Overall Study	STARTED	Chloroquine	10
Overall Study	STARTED	Placebo	10
Overall Study	STARTED	Dofetilide and Diltiazem	10
Overall Study	COMPLETED	Ranolazine	10
Overall Study	COMPLETED	Verapamil	9
Overall Study	COMPLETED	Lopinavir / Ritonavir	10
Overall Study	COMPLETED	Chloroquine	10

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events180

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal Discomfort	Gastrointestinal disorders	Ranolazine	0	10
other	Abdominal Discomfort	Gastrointestinal disorders	Verapamil	0	10
other	Abdominal Discomfort	Gastrointestinal disorders	Lopinavir / Ritonavir	3	10
other	Abdominal Discomfort	Gastrointestinal disorders	Chloroquine	0	10
other	Abdominal Discomfort	Gastrointestinal disorders	Placebo	0	10
other	Abdominal Discomfort	Gastrointestinal disorders	Dofetilide and Diltiazem	0	10
other	Abdominal Distention	Gastrointestinal disorders	Ranolazine	0	10
other	Abdominal Distention	Gastrointestinal disorders	Verapamil	0	10
other	Abdominal Distention	Gastrointestinal disorders	Lopinavir / Ritonavir	1	10
other	Abdominal Distention	Gastrointestinal disorders	Chloroquine	0	10

1 to 10 of 180Source ClinicalTrials.gov

See all 180 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ranolazine	0	10
Total, all-cause mortality	Verapamil	0	10
Total, all-cause mortality	Lopinavir / Ritonavir	0	10
Total, all-cause mortality	Chloroquine	0	10
Total, all-cause mortality	Placebo	0	10
Total, all-cause mortality	Dofetilide and Diltiazem	0	10
Total, other adverse events	Ranolazine	3	10
Total, other adverse events	Verapamil	5	10
Total, other adverse events	Lopinavir / Ritonavir	9	10
Total, other adverse events	Chloroquine	4	10

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28986934	BACKGROUND	PubMed
30121123	BACKGROUND	PubMed
30447156	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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