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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: Completed Phase 2 study, sponsored by Sarfez Pharmaceuticals.

NCT06206512 is a Phase 2 study that has completed, run by Sarfez Pharmaceuticals. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Within-subject difference in change from baseline in HRQoL total score between extended-release torsemide (ERT) and immediate-release torsemide (IRT) treatment periods. Clinical significance interpreted using a Patient Global Impression of Change (PGI-C)-anchored minimum clinically important difference (MCID).

Interventions

  • DRUG Extended release torsemide
  • DRUG Immediate release torsemide
  • DRUG Extended release torsemide placebo
  • DRUG Immediate release torsemide placebo

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2024-06-15
Est. Completion 2026-03-09
Phase Phase 2
Sarfez Pharmaceuticals

6 total trials

What the finished NCT06206512 record still lists

NCT06206512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 4 interventions - of which Extended release torsemide is the first listed.

NCT06206512 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT06206512's enrollment target sits among peer trials

24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT06206512, the US trial registry maintained by the National Library of Medicine. NCT06206512 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.