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NCT04675788 · ClinicalTrials.gov registry record · Phase 4
Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening
A Phase 4 study of Long QT Syndrome and Abnormalities, Drug-Induced, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 73
- Enrollment target
- 3
- Study locations
NCT04675788 is a Phase 4 study of Long QT Syndrome and Abnormalities, Drug-Induced that has completed, run by Indiana University. The registered enrollment target is 73 participants, below the 671-participant average among 7 other Long QT Syndrome trials with a reported enrollment target (89% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT04675788, a Phase 4 study of Long QT Syndrome and Abnormalities, Drug-Induced, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 73 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Progesterone
- DRUG Testosterone
- DRUG Ibutilide
Study Locations (3)
Indiana
- Indiana Clinical Research Center - Indianapolis
- Indiana University - Indianapolis
- Purdue University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2021-09-02 |
| Est. Completion | 2025-04-16 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04675788
The ClinicalTrials.gov registry entry for NCT04675788 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 671-participant average among 7 other Long QT Syndrome trials with a reported enrollment target (89% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Long QT Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04675788 reports 3 study locations spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT04675788 about?
NCT04675788 is a clinical study titled "Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening". 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 a...
What is the current status of trial NCT04675788?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 73 participants. The study started on 2021-09-02. Estimated completion is 2025-04-16.
What conditions does trial NCT04675788 study?
This clinical trial studies the following conditions: Long QT Syndrome, Abnormalities, Drug-Induced.
What interventions are being tested in trial NCT04675788?
The interventions under investigation include: Placebo (DRUG), Progesterone (DRUG), Testosterone (DRUG), Ibutilide (DRUG).
Who is sponsoring clinical trial NCT04675788?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04675788 being conducted?
This trial has 3 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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