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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: Recruiting Phase 1 study of Type 2 Diabetes and High Blood Pressure, sponsored by University of Texas Southwestern Medical Center.
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 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The ability of a polypill to improve or prevent declines in exercise capacity as measured by changes in peak oxygen uptake at exercise will be assessed.
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 |
What NCT06143566 shows while recruiting
NCT06143566 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06143566's enrollment target sits among peer trials
200 99th of 327 higher than 223 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes 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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