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NCT02142881 · ClinicalTrials.gov registry record · Phase 3
Treatment of Masked Hypertension
A Phase 3 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 3
- Development phase
- 4
- Enrollment target
NCT02142881: Completed Phase 3 study, sponsored by University of Minnesota.
NCT02142881 is a Phase 3 study that has completed, run by University of Minnesota. The registered enrollment target is 4 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02142881, a Phase 3 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4 participants
- Enrollment target
Study Summary
To date, most observational and all intervention studies have defined hypertension on the basis of clinic blood pressure (BP). Measurement of BP outside the clinic with home or ambulatory BP provides a better estimate of the risk of cardiovascular disease and all-cause mortality. Using clinic and ambulatory BPs, patients can be categorized as normotensive (normal clinic and ambulatory BPs), white-coat hypertension (elevated clinic BP with normal ambulatory BP), masked hypertension (normal clinic BP with elevated ambulatory BP), and sustained hypertension (elevated clinic and ambulatory BP). Approximately one third of patients with chronic kidney disease (CKD) with normal clinic BP have elevated ambulatory BP (masked hypertension). We demonstrated that, among participants from the Chronic Renal Insufficiency Cohort (CRIC) study, low estimated glomerular filtration rate (eGFR) and elevated proteinuria are associated with increased odds of masked hypertension. Additionally, participants with masked hypertension had increased risk for target organ damage as assessed by left ventricular mass and pulse wave velocity. These results in participants with CKD are consistent with prior studies in patients with normal renal function that demonstrated a two-fold increased risk for cardiovascular events in patients with masked hypertension compared to patients with normal clinic and ambulatory BP. Despite this elevated risk for adverse outcomes, patients with masked hypertension have been excluded from hypertension trials because of their normal clinic BP. Therefore, it is unknown whether the reduction in target organ damage and adverse cardiovascular outcomes associated with treatment of hypertension extends to patients with masked hypertension. To address this important gap in knowledge, we are planning a randomized, controlled trial to evaluate whether antihypertensive treatment can modify BP patterns in patients with masked hypertension, that is, convert them to controlled cl
Primary Outcome
Percentage of participants with masked hypertension defined as a 24hr ambulatory systolic blood pressure \>130 mmHg and a clinic systolic blood pressure \<140 mmHg
Interventions
- OTHER Usual care
- OTHER Antihypertensive medication intensification
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-06 |
| Est. Completion | 2017-12-07 |
| Phase | Phase 3 |
What the finished NCT02142881 record still lists
NCT02142881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Usual care is the first listed.
NCT02142881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02142881 about?
NCT02142881 is a clinical study titled "Treatment of Masked Hypertension". To date, most observational and all intervention studies have defined hypertension on the basis of clinic blood pressure (BP). Measurement of BP outside the clinic with home or ambulatory BP provides a better estimate of the risk of cardiovascular disease and all-cause mortality. Using clinic and am...
What is the current status of trial NCT02142881?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4 participants. The study started on 2014-06. Estimated completion is 2017-12-07.
What interventions are being tested in trial NCT02142881?
The interventions under investigation include: Usual care (OTHER), Antihypertensive medication intensification (OTHER).
Who is sponsoring clinical trial NCT02142881?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02142881's enrollment target sits among peer trials
4 1998th of 2000 higher than 2 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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