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NCT06206512 · ClinicalTrials.gov registry record · Phase 2
Effect of Extended Release Torsemide in Patients With Congestive Heart Failure and Overactive Bladder
A Phase 2 study, sponsored by Sarfez Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT06206512 is a Phase 2 study that has completed, run by Sarfez Pharmaceuticals. The registered enrollment target is 24 participants.
The verdict
NCT06206512, a Phase 2 study, has completed, sponsored by Sarfez Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
This research study is being done to compare the effectiveness two drugs: an Extended Release Torsemide (ERT) versus generic Immediate Release Torsemide (IRT) in reducing the worsening of symptoms of Overactive Bladder (OAB, i.e., frequency, urgency, or urgency incontinence) in patients with chronic congestive heart failure (CHF). This study will include CHF patients who experience worsening (OAB) symptoms with use of a loop diuretic. The total duration of the study is about eight weeks with a total of nine visits. There will be a screening visit that lasts one to two hours. The screening visit includes history and physical exams, blood draws, and urine analysis. If eligible for the study, participants will receive either generic torsemide or extended release torsemide for the first four weeks. Participants will do a virtual research visit on week one, two and three to submit a symptom diary and answer a questionnaire about urinary symptoms. At four weeks, history and physician exam will be done and blood will be collected. Participants will be assigned to receive either extended release torsemide (if they initially received generic torsemide) and generic torsemide (if they initially received extended release torsemide) for the next four weeks. Participants will attend virtual research visits on week five, six and seven to submit a symptom diary and answer a questionnaire about urinary symptoms. At the end of the study in week eight, they will have history and physical exams and blood draws. Some risks from the study may include side effects of torsemide like acute kidney injury, fluid/electrolyte loss, hypersensitivity reactions and reversible hearing loss/tinnitus.
Interventions
- DRUG Extended release torsemide
- DRUG Immediate release torsemide
- DRUG Extended release torsemide placebo
- DRUG Immediate release torsemide placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-06-15 |
| Est. Completion | 2026-03-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06206512
The ClinicalTrials.gov registry entry for NCT06206512 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sarfez Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Extended release torsemide is the first listed.
NCT06206512 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06206512 about?
NCT06206512 is a clinical study titled "Effect of Extended Release Torsemide in Patients With Congestive Heart Failure and Overactive Bladder". This research study is being done to compare the effectiveness two drugs: an Extended Release Torsemide (ERT) versus generic Immediate Release Torsemide (IRT) in reducing the worsening of symptoms of Overactive Bladder (OAB, i.e., frequency, urgency, or urgency incontinence) in patients with chronic...
What is the current status of trial NCT06206512?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2024-06-15. Estimated completion is 2026-03-09.
What interventions are being tested in trial NCT06206512?
The interventions under investigation include: Extended release torsemide (DRUG), Immediate release torsemide (DRUG), Extended release torsemide placebo (DRUG), Immediate release torsemide placebo (DRUG).
Who is sponsoring clinical trial NCT06206512?
This trial is sponsored by Sarfez Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
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