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NCT06785116 · ClinicalTrials.gov registry record · Phase 4
A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
A Phase 4 study of Gestational Hypertension and Hypertension in Pregnancy, sponsored by University of Michigan.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT06785116 is a Phase 4 study of Gestational Hypertension and Hypertension in Pregnancy that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 200 participants, below the 1,347-participant average among 18 other Gestational Hypertension trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06785116, a Phase 4 study of Gestational Hypertension and Hypertension in Pregnancy, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
This trial is a pilot-scale, single institution randomized, placebo-controlled trial to assess the feasibility, acceptability, and efficacy of administering dapagliflozin for cardiovascular risk reduction in the postpartum period. The target population is patients at high risk of adverse cardiovascular outcomes within five years post-delivery. Eligible participants will be randomized to receive either: 1) dapagliflozin (10mg daily) for six months (DAPA group) or 2) an orally administered, daily placebo (Control group). The study hypothesizes: The dapagliflozin group will have higher cardiovascular risk reduction scores than the Control Group.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dapagliflozin 10mg Tab
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-03-02 |
| Est. Completion | 2028-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06785116
The ClinicalTrials.gov registry entry for NCT06785116 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,347-participant average among 18 other Gestational Hypertension trials with a reported enrollment target (85% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Gestational Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06785116 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT06785116 about?
NCT06785116 is a clinical study titled "A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)". This trial is a pilot-scale, single institution randomized, placebo-controlled trial to assess the feasibility, acceptability, and efficacy of administering dapagliflozin for cardiovascular risk reduction in the postpartum period. The target population is patients at high risk of adverse cardiovascu...
What is the current status of trial NCT06785116?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2025-03-02. Estimated completion is 2028-08.
What conditions does trial NCT06785116 study?
This clinical trial studies the following conditions: Gestational Hypertension, Hypertension in Pregnancy, Pre-Eclampsia, Cardiovascular Complication, Superimposed Pre-Eclampsia.
What interventions are being tested in trial NCT06785116?
The interventions under investigation include: Placebo (DRUG), Dapagliflozin 10mg Tab (DRUG).
Who is sponsoring clinical trial NCT06785116?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06785116 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.