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NCT01446003 · ClinicalTrials.gov registry record · Phase 1
A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01446003: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT01446003 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01446003, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This study will evaluate the effect of treatment with multiple doses of MK-8457 on systolic blood pressure in participants with mild to moderate hypertension in addition to safety and tolerability. The study hypothesis is that MK-8457 does not increase systolic blood pressure to a clinically significant extent, as measured by 24-hour mean ambulatory systolic blood pressure change from baseline after 10 days of dosing.
Primary Outcome
SBP was measured using ambulatory blood pressure monitoring (ABPM) on Day -1 and Day 10 of each treatment period. The 24-hour least squares (LS) mean ambulatory SBP change from baseline was then determined for Day 10, the last day of multiple dose treatment. Baseline is defined as the average 24-hour SBP for each participant on Day -1. Increased values represent an increase in hypertensive severity.
Interventions
- DRUG MK-8457
- DRUG Placebo for MK-8457
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-10-25 |
| Est. Completion | 2012-03-03 |
| Phase | Phase 1 |
What the finished NCT01446003 record still lists
NCT01446003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which MK-8457 is the first listed.
NCT01446003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01446003 about?
NCT01446003 is a clinical study titled "A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1)". This study will evaluate the effect of treatment with multiple doses of MK-8457 on systolic blood pressure in participants with mild to moderate hypertension in addition to safety and tolerability. The study hypothesis is that MK-8457 does not increase systolic blood pressure to a clinically signifi...
What is the current status of trial NCT01446003?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2011-10-25. Estimated completion is 2012-03-03.
What interventions are being tested in trial NCT01446003?
The interventions under investigation include: MK-8457 (DRUG), Placebo for MK-8457 (DRUG).
Who is sponsoring clinical trial NCT01446003?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01446003's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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