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NCT04019652 · ClinicalTrials.gov registry record · Phase 1
The Effect of CS-3150 Exposure on Corrected QT (QTc) Interval Duration in Healthy Volunteers
A Phase 1 study of Hypertension and Mineralocorticoid Receptor Antagonist, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT04019652: Completed Phase 1 study of Hypertension and Mineralocorticoid Receptor Antagonist, sponsored by Daiichi Sankyo.
NCT04019652 is a Phase 1 study of Hypertension and Mineralocorticoid Receptor Antagonist that has completed, run by Daiichi Sankyo. The registered enrollment target is 55 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04019652, a Phase 1 study of Hypertension and Mineralocorticoid Receptor Antagonist, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test if a study drug (CS-3150) will affect the heart rate in healthy males and females. Two doses of the study drug will be tested. Heart rate is not expected to be different between the study groups.
Primary Outcome
On the electrocardiogram tracing, the estimated difference in least square means will be reported between each CS-3150 dose level and placebo in QTc change from baseline.
Conditions Studied
Interventions
- DRUG Moxifloxacin
- DRUG CS-3150
- DRUG Placebo matching moxifloxacin tablet
- DRUG Placebo matching CS-3150
Study Locations (1)
Texas
- Worldwide Clinical Trials - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2015-11-19 |
| Est. Completion | 2015-12-23 |
| Phase | Phase 1 |
What the finished NCT04019652 record still lists
NCT04019652 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Hypertension appearing as the primary indexed condition, and to 4 interventions - of which Moxifloxacin is the first listed.
NCT04019652 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04019652 about?
NCT04019652 is a clinical study titled "The Effect of CS-3150 Exposure on Corrected QT (QTc) Interval Duration in Healthy Volunteers". This study will test if a study drug (CS-3150) will affect the heart rate in healthy males and females. Two doses of the study drug will be tested. Heart rate is not expected to be different between the study groups.
What is the current status of trial NCT04019652?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2015-11-19. Estimated completion is 2015-12-23.
What conditions does trial NCT04019652 study?
This clinical trial studies the following conditions: Hypertension, Mineralocorticoid Receptor Antagonist.
What interventions are being tested in trial NCT04019652?
The interventions under investigation include: Moxifloxacin (DRUG), CS-3150 (DRUG), Placebo matching moxifloxacin tablet (DRUG), Placebo matching CS-3150 (DRUG).
Who is sponsoring clinical trial NCT04019652?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04019652 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04019652's enrollment target sits among peer trials
55 360th of 470 higher than 109 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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