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NCT06143566 · ClinicalTrials.gov registry record · Phase 1
Polypill for Prevention of Cardiomyopathy
A Phase 1 study of Type 2 Diabetes and High Blood Pressure, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT06143566 is a Phase 1 study of Type 2 Diabetes and High Blood Pressure that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 200 participants, below the 1,102-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06143566, a Phase 1 study of Type 2 Diabetes and High Blood Pressure, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will investigate the utility of a polypill-based strategy for patients with type 2 diabetes mellitus and high risk of heart failure (HF), as assessed via the WATCH-DM risk score. Polypill therapy will consist of empagliflozin 12.5 mg, losartan 25, 50 or 100 mg, and finerenone 10 mg daily. The study duration is 6 months, and participants will be randomized to either polypill therapy or simultaneous prescription of the individual drugs. The primary outcome is change in peak VO2 and adherence to usual care. The investigators hypothesize that the use of a polypill is feasible and improves medication adherence and peak VO2 as compared to those receiving usual care.
Conditions Studied
Interventions
- DRUG Polypill
- DRUG Combined prescription of the individual medications
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-03-11 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06143566
The ClinicalTrials.gov registry entry for NCT06143566 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,102-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (82% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Polypill is the first listed.
NCT06143566 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06143566 about?
NCT06143566 is a clinical study titled "Polypill for Prevention of Cardiomyopathy". This study will investigate the utility of a polypill-based strategy for patients with type 2 diabetes mellitus and high risk of heart failure (HF), as assessed via the WATCH-DM risk score. Polypill therapy will consist of empagliflozin 12.5 mg, losartan 25, 50 or 100 mg, and finerenone 10 mg daily....
What is the current status of trial NCT06143566?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2024-03-11. Estimated completion is 2027-12-01.
What conditions does trial NCT06143566 study?
This clinical trial studies the following conditions: Type 2 Diabetes, High Blood Pressure.
What interventions are being tested in trial NCT06143566?
The interventions under investigation include: Polypill (DRUG), Combined prescription of the individual medications (DRUG).
Who is sponsoring clinical trial NCT06143566?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06143566 being conducted?
This trial has 1 study location across Texas. 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.