Back to resultsNovel Approaches for Minimizing Drug-Induced QT Interval Lengthening
Primary Purpose
Long QT Syndrome, Abnormalities, Drug-Induced
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Progesterone
Ibutilide
Testosterone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Long QT Syndrome
Eligibility Criteria
Inclusion Criteria:
Postmenopausal Women:
- Age 50-85 years old
- Postmenopausal (have not has a menstrual period for 12 months or longer)
Exclusion Criteria:
Postmenopausal women:
- Subject reported history of breast, uterine and ovarian cervical cancer
- Subject reported history of hysterectomy and/or ovariectomy
- Subject reported taking any hormone replacement therapy (prescription, nonprescription or herbal supplement)
- Weight < 60 kg at time of screening visit
- Weight >135 kg at time of screening visit
- Serum K+ <3.6 mEq/L at time of any ibutilide dosing visit
- Serum Mg2+ <1.8 mg/dL at time of screening visit
- Hematocrit <26%
- AST or ALT > 3x the upper limit of normal (determined by testing lab ranges) at the time of screening visit
- Baseline Bazett's-corrected QTc >450 ms (during any visit prior to ibutilide dosing)
- Baseline QRS > 120 ms (at time of baseline visit)
- Diagnosis of heart failure due to reduced or preserved ejection fraction
- Subject reported family history of long QT syndrome, TdP, or sudden cardiac death not associated with acute myocardial infarction
- Self-reported personal history of long QT syndrome, sudden cardiac death not associated with acute myocardial infarction
- Subject reported history any prolonged arrhythmia for which treatment was required
- Subject reported history of a myocardial infarction
- Subject reported history of coronary artery disease
- Sustained arrythmia found at baseline screening prior to any study visit including atrial fibrillation, atrial flutter, junctional rhythm, heart block (any)
- Permanently paced ventricular rhythm
- Current reported use of any QT prolonging medication. Investigator will check the current QT drugs list at www.crediblemeds.org during screening.
- Current reported use of any moderate or strong inhibitors of cytochrome P450 (CYP) 3A4, 3A5, or 3A7
- Current reported use of any inducers of cytochrome P-450 (CYP) 3A4, 3A5 or 3A7
Inclusion Criteria:
Older Men:
• Age 65 years old to 90 years old
Exclusion Criteria:
- Older men:
- Subject reported diagnosis of benign prostatic hyperplasia
- Subject reported history of breast or prostate cancer
- Weight < 60 kg at time of screening visit
- Weight >135 kg at time of screening visit
- Serum K+ <3.6 mEq/L at time of any ibutilide dosing visit
- Serum Mg2+ <1.8 mg/dL at time of screening visit
- Hematocrit <26%
- AST or ALT > 3x the upper limit of normal (determined by testing lab ranges) at the time of screening visit
- Baseline Bazett's-corrected QTc >450 ms (during any visit prior to ibutilide dosing)
- Baseline QRS > 120 ms (at time of baseline visit)
- Diagnosis of heart failure due to reduced or preserved ejection fraction
- Subject reported family history of long QT syndrome, TdP, or sudden cardiac death not associated with acute myocardial infarction
- Self-reported personal history of long QT syndrome, arrhythmias (including atrial fibrillation) or sudden cardiac death not associated with acute myocardial infarction
- Sustained arrythmia found at baseline screening prior to any study visit including atrial fibrillation, atrial flutter, junctional rhythm, heart block (any)
- Permanently paced ventricular rhythm
- Current reported use of any QT prolonging medication (Investigator will check current list of QT prolonging medications listed at www.crediblemeds.org at the time of screening for the most up to date list.
- Current reported use of any moderate or strong inhibitors of cytochrome P450 (CYP) 3A
- Current reported use of any inducers of cytochrome P-450 (CYP) 3A4, 3A5 or 3A7
Sites / Locations
- Indiana Clinical Research CenterRecruiting
- Indiana UniversityRecruiting
- Purdue University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Postmenopausal women: Progesterone
Postmenopausal women: Placebo
Men 65 years of age or older: Testosterone
Men 65 years of age or older: Placebo
Arm Description
Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Subjects will receive treatment with transdermal testosterone 1% (100 mg) every morning for 3 days
Subjects will receive treatment with transdermal placebo every morning for 3 days
Outcomes
Primary Outcome Measures
Pre-ibutilide QT-F and QT-Fram intervals
QT intervals will be corrected for heart rate using two methods: the Fridericia method and the Framingham method
Pre-ibutilide QT-F and QT-Fram intervals
QT intervals will be corrected for heart rate using two methods: the Fridericia method and the Framingham method
Maximum post-ibutilide QT-F and QT-Fram intervals
Maximum post-ibutilide QT-F and QT-Fram intervals
Percent change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals
Percent change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals
Area under the QT-F and QT-Fram versus time curves during and for 1 hour following ibutilide infusion
Area under the QT-F and QT-Fram versus time curves during and for 1 hour
Area under the QT-F and QT-Fram versus time curves during and for 8 hours following ibutilide infusion
Area under the QT-F and QT-Fram versus time curves during and for 8 hours following ibutilide infusion
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Maximum post-ibutilide J-Tpeakc intervals
Maximum post-ibutilide J-Tpeakc intervals
Percent change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals
Percent change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals
Area under the J-Tpeakc versus time curve during and for 1 hour following ibutilide infusion
Area under the J-Tpeakc versus time curve during and for 1 hour following ibutilide infusion
Area under the J-Tpeakc versus time curve during and for 8 hours following ibutilide infusion
Area under the J-Tpeakc versus time curve during and for 8 hours following ibutilide infusion
Pre-ibutilide Tpeak-Tend intervals
Pre-ibutilide Tpeak-Tend intervals
Pre-ibutilide Tpeak-Tend intervals
Pre-ibutilide Tpeak-Tend intervals
Maximum post-ibutilide Tpeak-Tend intervals
Maximum post-ibutilide Tpeak-Tend intervals
Percent change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals
Percent change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals
Area under the Tpeak-Tend versus time curves during and for 1 hour following ibutilide infusion
Area under the Tpeak-Tend versus time curves during and for 1 hour following ibutilide infusion
Area under the Tpeak-Tend versus time curves during and for 8 hours following ibutilide infusion
Area under the Tpeak-Tend versus time curves during and for 8 hours following ibutilide infusion
Secondary Outcome Measures
Full Information
NCT ID
NCT04675788
First Posted
December 4, 2020
Last Updated
July 28, 2023
Sponsor
Indiana University
Collaborators
Purdue University, National Heart, Lung, and Blood Institute (NHLBI), Harvard University, Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04675788
Brief Title
Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening
Official Title
Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Purdue University, National Heart, Lung, and Blood Institute (NHLBI), Harvard University, Cedars-Sinai Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research will determine if: 1) Oral progesterone attenuates drug-induced QT interval, J-Tpeak and Tpeak-Tend lengthening in postmenopausal women 50 years of age or older, and 2) Transdermal testosterone attenuates drug-induced QT interval, J-Tpeak and Tpeak-Tend lengthening in men 65 years of age or older. This investigation will consist of two concurrent prospective, randomized, double-blind, placebo-controlled crossover-design studies in a) Postmenopausal women, and b) Men 65 years of age or older. Study 1: Each postmenopausal woman will take progesterone or placebo capsules for 1 week. After a 14-day "washout" (no progesterone or placebo) each subject will then take the alternative therapy (progesterone or placebo) for 1 week. After 7 days of each treatment, subjects will present to the clinical research center to receive a small dose of the QT interval-lengthening drug ibutilide, and the effect on the QT, J-Tpeak and Tpeak-Tend intervals during the progesterone and placebo phases will be compared. Study 2: Each man 65 years of age or older will apply transdermal testosterone or transdermal placebo gel for 3 days. After a 7-day "washout" (no testosterone or placebo) each subject will then apply the alternative therapy (testosterone or placebo gel) for 1 week. After 3 days of each treatment, subjects will present to the clinical research center to receive a small dose of the QT interval-lengthening drug ibutilide, and the effect on the QT, J-Tpeak and Tpeak-Tend intervals during the testosterone and placebo phases will be compared.
Detailed Description
Torsades de pointes (TdP) is a ventricular tachycardia associated with prolongation of the corrected QT (QTc) interval, and which may be caused by > 150 widely used drugs. TdP results in catastrophic outcomes, including sudden cardiac death. Older age is a risk factor for drug-induced TdP, possibly due to declining serum progesterone and testosterone concentrations in postmenopausal women and men, respectively. The ECG biomarkers J-Tpeak and Tpeak-Tend, represent early and late repolarization, respectively, as well as dispersion of repolarization (Tpeak-Tend). Preclinical evidence and preliminary data from our group indicate that progesterone and testosterone exert protective effects against drug-induced prolongation of ventricular repolarization. Effective means of reducing the risk of drug-induced QTc interval prolongation and TdP in high risk populations requiring therapy with QTc-prolonging drugs have not been identified, and the effects of sex hormones on early vs late ventricular repolarization and dispersion of repolarization are unknown. The objectives of this research are to evaluate novel therapeutic approaches to attenuate drug-induced QTc lengthening. Our central hypothesis is that drug-induced QTc lengthening is attenuated by administration of oral progesterone and transdermal testosterone. Specific Aim 1: Determine the efficacy of oral progesterone as a preventive method to attenuate drug-induced QTc interval lengthening in postmenopausal women. Specific Aim 2: Determine the efficacy of transdermal testosterone as a preventive method to attenuate drug-induced QTc interval lengthening in men ≥ 65 years of age. Specific Aim 3a: Determine the influence of oral progesterone on drug-induced lengthening of early and late ventricular repolarization in postmenopausal women. Specific Aim 3b: Determine the influence of transdermal testosterone on drug-induced lengthening of early and late ventricular repolarization in men ≥ 65 years of age. Specific Aims 1&3a will be achieved via a prospective, randomized, double-blind, placebo-controlled two-way crossover study in postmenopausal women age ≥ 50 years (n=48). Each subject will take oral progesterone 400 mg or matching placebo daily for 7 days (≥ 14-day washout period between phases). On day 7, each subject will receive a single dose of the QTc-lengthening drug ibutilide 0.003 mg/kg. Specific Aims 2&3b will be achieved via a prospective, randomized, double-blind, placebo-controlled two-way crossover study in men ≥ 65 years of age (n=35). Each subject will apply transdermal testosterone 1% 100 mg or transdermal placebo once daily for 3 days (≥ 7-day washout period between phases). On day 7, each subject will ibutilide 0.003 mg/kg. In both studies, post-ibutilide QT, J-Tpeak and Tpeak-Tend intervals and serum ibutilide concentrations will be determined serially. Primary outcome measures: 1) Maximum post-ibutilide QTc intervals, 2) Maximum post-ibutilide % change in QTc intervals, 3) Area under the QTc interval-time curves, and 4) J-Tpeak and Tpeak-Tend intervals. This research will identify effective approaches for reducing the risk of drug-induced QTc interval prolongation in high-risk patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long QT Syndrome, Abnormalities, Drug-Induced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Postmenopausal women: Progesterone
Arm Type
Experimental
Arm Description
Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Arm Title
Postmenopausal women: Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Arm Title
Men 65 years of age or older: Testosterone
Arm Type
Experimental
Arm Description
Subjects will receive treatment with transdermal testosterone 1% (100 mg) every morning for 3 days
Arm Title
Men 65 years of age or older: Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive treatment with transdermal placebo every morning for 3 days
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Description
Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days
Intervention Type
Drug
Intervention Name(s)
Ibutilide
Other Intervention Name(s)
Corvert
Intervention Description
Ibutilide 0.003 mg/kg administered to all subjects to modestly lengthen the QT interval
Intervention Type
Drug
Intervention Name(s)
Testosterone
Other Intervention Name(s)
Androgel
Intervention Description
Subjects will apply transdermal testosterone gel once daily every morning for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lactose capsules
Primary Outcome Measure Information:
Title
Pre-ibutilide QT-F and QT-Fram intervals
Description
QT intervals will be corrected for heart rate using two methods: the Fridericia method and the Framingham method
Time Frame
Morning of day 8 (after 7 days of progesterone/placebo)
Title
Pre-ibutilide QT-F and QT-Fram intervals
Description
QT intervals will be corrected for heart rate using two methods: the Fridericia method and the Framingham method
Time Frame
Morning of day 4 (after 3 days of testosterone/placebo)
Title
Maximum post-ibutilide QT-F and QT-Fram intervals
Description
Maximum post-ibutilide QT-F and QT-Fram intervals
Time Frame
From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Title
Percent change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals
Description
Percent change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals
Time Frame
From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Title
Area under the QT-F and QT-Fram versus time curves during and for 1 hour following ibutilide infusion
Description
Area under the QT-F and QT-Fram versus time curves during and for 1 hour
Time Frame
From initiation of ibutilide infusion and for 1 hour after the end of ibutilide infusion
Title
Area under the QT-F and QT-Fram versus time curves during and for 8 hours following ibutilide infusion
Description
Area under the QT-F and QT-Fram versus time curves during and for 8 hours following ibutilide infusion
Time Frame
From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Title
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Description
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Time Frame
Morning of day 8 (after 7 days of progesterone/placebo)
Title
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Description
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Time Frame
Morning of day 4 (after 3 days of testosterone/placebo)
Title
Maximum post-ibutilide J-Tpeakc intervals
Description
Maximum post-ibutilide J-Tpeakc intervals
Time Frame
From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Title
Percent change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals
Description
Percent change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals
Time Frame
From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Title
Area under the J-Tpeakc versus time curve during and for 1 hour following ibutilide infusion
Description
Area under the J-Tpeakc versus time curve during and for 1 hour following ibutilide infusion
Time Frame
From initiation of ibutilide infusion and for 1 hour after the end of ibutilide infusion
Title
Area under the J-Tpeakc versus time curve during and for 8 hours following ibutilide infusion
Description
Area under the J-Tpeakc versus time curve during and for 8 hours following ibutilide infusion
Time Frame
From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Title
Pre-ibutilide Tpeak-Tend intervals
Description
Pre-ibutilide Tpeak-Tend intervals
Time Frame
Morning of day 8 (after 7 days of progesterone/placebo)
Title
Pre-ibutilide Tpeak-Tend intervals
Description
Pre-ibutilide Tpeak-Tend intervals
Time Frame
Morning of day 4 (after 3 days of testosterone/placebo)
Title
Maximum post-ibutilide Tpeak-Tend intervals
Description
Maximum post-ibutilide Tpeak-Tend intervals
Time Frame
From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Title
Percent change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals
Description
Percent change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals
Time Frame
From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Title
Area under the Tpeak-Tend versus time curves during and for 1 hour following ibutilide infusion
Description
Area under the Tpeak-Tend versus time curves during and for 1 hour following ibutilide infusion
Time Frame
From initiation of ibutilide infusion and for 1 hour after the end of ibutilide infusion
Title
Area under the Tpeak-Tend versus time curves during and for 8 hours following ibutilide infusion
Description
Area under the Tpeak-Tend versus time curves during and for 8 hours following ibutilide infusion
Time Frame
From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Other Pre-specified Outcome Measures:
Title
Adverse effects of oral progesterone and placebo
Description
Adverse effects of oral progesterone and oral placebo
Time Frame
Adverse effects will be assessed via telephone calls to subjects between days 2 and 4 and between days 5 and 7 of oral progesterone and oral placebo
Title
Adverse effects of transdermal testosterone and transdermal placebo
Description
Adverse effects of transdermal testosterone and transdermal placebo
Time Frame
Adverse effects will be assessed via telephone calls to subjects between days 1 and 3 of transdermal testosterone and transdermal placebo
Title
Adverse effects of ibutilide
Description
Adverse effects of ibutilide
Time Frame
Adverse effects of ibutilide will be assessed during the 10-minute intravenous infusion and for 8 hours following the infusion of ibutilide
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Postmenopausal Women:
Age 50-99 years old
Postmenopausal (have not has a menstrual period for 12 months or longer)
Exclusion Criteria:
Postmenopausal women:
Subject reported history of breast, uterine and ovarian cervical cancer
Subject reported history of hysterectomy and/or ovariectomy
Subject reported taking any hormone replacement therapy (prescription, nonprescription or herbal supplement)
Weight < 60 kg at time of screening visit
Weight >135 kg at time of screening visit
Serum K+ <3.6 mEq/L at time of any ibutilide dosing visit
Serum Mg2+ <1.8 mg/dL at time of screening visit
Hematocrit <26%
AST or ALT > 3x the upper limit of normal (determined by testing lab ranges) at the time of screening visit
Baseline Bazett's-corrected QTc >450 ms (during any visit prior to ibutilide dosing)
Baseline QRS > 120 ms (at time of baseline visit)
Diagnosis of heart failure due to reduced or preserved ejection fraction
Subject reported family history of long QT syndrome, TdP, or sudden cardiac death not associated with acute myocardial infarction
Self-reported personal history of long QT syndrome, sudden cardiac death not associated with acute myocardial infarction
Subject reported history any prolonged arrhythmia for which treatment was required
Subject reported history of a myocardial infarction
Subject reported history of coronary artery disease
Sustained arrythmia found at baseline screening prior to any study visit including atrial fibrillation, atrial flutter, junctional rhythm, heart block (any)
Permanently paced ventricular rhythm
Current reported use of any QT prolonging medication. Investigator will check the current QT drugs list at www.crediblemeds.org during screening.
Current reported use of any moderate or strong inhibitors of cytochrome P450 (CYP) 3A4, 3A5, or 3A7
Current reported use of any inducers of cytochrome P-450 (CYP) 3A4, 3A5 or 3A7
Inclusion Criteria:
Older Men:
• Age 65 years old to 99 years old
Exclusion Criteria:
Older men:
Subject reported diagnosis of benign prostatic hyperplasia
Subject reported history of breast or prostate cancer
Weight < 60 kg at time of screening visit
Weight >135 kg at time of screening visit
Serum K+ <3.6 mEq/L at time of any ibutilide dosing visit
Serum Mg2+ <1.8 mg/dL at time of screening visit
Hematocrit <26%
AST or ALT > 3x the upper limit of normal (determined by testing lab ranges) at the time of screening visit
Baseline Bazett's-corrected QTc >450 ms (during any visit prior to ibutilide dosing)
Baseline QRS > 120 ms (at time of baseline visit)
Diagnosis of heart failure due to reduced or preserved ejection fraction
Subject reported family history of long QT syndrome, TdP, or sudden cardiac death not associated with acute myocardial infarction
Self-reported personal history of long QT syndrome, arrhythmias (including atrial fibrillation) or sudden cardiac death not associated with acute myocardial infarction
Sustained arrythmia found at baseline screening prior to any study visit including atrial fibrillation, atrial flutter, junctional rhythm, heart block (any)
Permanently paced ventricular rhythm
Current reported use of any QT prolonging medication (Investigator will check current list of QT prolonging medications listed at www.crediblemeds.org at the time of screening for the most up to date list.
Current reported use of any moderate or strong inhibitors of cytochrome P450 (CYP) 3A
Current reported use of any inducers of cytochrome P-450 (CYP) 3A4, 3A5 or 3A7
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James E Tisdale, PharmD
Phone
317-880-5418
Email
jtisdale@purdue.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Heather A Jaynes, MSN
Phone
317-847-2094
Email
hwroblew@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James E Tisdale, PharmD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana Clinical Research Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Denne, MD
Phone
317-274-4920
Email
sdenne@iupui.edu
First Name & Middle Initial & Last Name & Degree
Sharon Cromer
Phone
317-278-3446
Email
scromer2@iupui.edu
First Name & Middle Initial & Last Name & Degree
James E Tisdale, BSC, PharmD
First Name & Middle Initial & Last Name & Degree
Heather Jaynes, MSN
First Name & Middle Initial & Last Name & Degree
Richard J Kovacs, MD
First Name & Middle Initial & Last Name & Degree
Kevin M Sowinski, PharmD
First Name & Middle Initial & Last Name & Degree
David Flockhart, MD, PhD
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James E Tisdale, PharmD
Phone
317-880-5418
Email
jtisdale@purdue.edu
Facility Name
Purdue University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James E Tisdale, BSc, PharmD
Phone
317-880-5418
Email
jtisdale@purdue.edu
First Name & Middle Initial & Last Name & Degree
Heather Jaynes, MSN
Phone
317-847-2094
Email
hwroblew@iu.edu
First Name & Middle Initial & Last Name & Degree
James E Tisdale, BSc, PharmD
First Name & Middle Initial & Last Name & Degree
Brian R Overholser, PharmD
First Name & Middle Initial & Last Name & Degree
Heather A Jaynes, MSN
First Name & Middle Initial & Last Name & Degree
Richard J Kovacs, MD
First Name & Middle Initial & Last Name & Degree
Kevin M Sowinski, PharmD
12. IPD Sharing Statement
Plan to Share IPD
No
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Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening
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