TerminatedNCT03509545Updated Apr 24, 2026

Comparison of Once Daily 40 mg Torsemide With Twice-daily 40 mg Furosemide

A Phase 1 interventional study of CHF Patients: ER Torsemide 40 mg and CHF Patients: Furosemide 40 mg in Body Weight Changes, sponsored by Sarfez Pharmaceuticals, Inc.. Terminated at 1 site in India. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Sarfez Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Why this study was terminated

recruitment issues

Phase: Phase 1
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: Male

Study summary

To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice daily Furosemide on 24-hour sodium excretion.

Read the detailed description

To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice-daily Furosemide on changes in body weight after two weeks of treatment. To compare the frequency and volume of urine passed in 24 hours. To compare the patients' quality of life and levels of natriuretic peptide between the two sets of patients.

Conditions studied

Body Weight Changes

Browse trials for

Body Weight Changes 212

Keywords

natriuresis

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: Male
Accepts healthy volunteers: No

Inclusion criteria

Patients of either gender over 18 years of age with clinical diagnosis of CHF and on a stable dose of 40 mg Furosemide.

Exclusion criteria

Exclusion Criteria:

Requirement for any other diuretic, history of cardiac dysrhythmia, other concurrent cardiovascular illness.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
CHF Patients: ER Torsemide 40 mg
CHF patients will be given 40 mg ER Torsemide
Drug: CHF Patients: ER Torsemide 40 mg
Active comparator
CHF Patients: Furosemide 40 mg
CHF patients are on 40 mg of Furosemide
Drug: CHF Patients: Furosemide 40 mg

Interventions

DrugCHF Patients: ER Torsemide 40 mg
ER Torsemide 40mg given once daily to CHF patients
Also known as: Demadex
DrugCHF Patients: Furosemide 40 mg
Stable CHF patients taking twice-daily 40 mg Furosemide
Also known as: Lasix

What researchers measure

Primary outcomes

change in 24-hour sodium excretion compared to baseline
the difference in 24 hour sodium excretion between ER Torsemide and Furosemide
Time frame: 24 hours

Secondary outcomes

Changes in body weight
Body weight changes will be compared between the two arms
Time frame: 2 weeks

Study locations

1 site

Syngene International
Bangalore, Karnataka 560099, India

Registry details

Key details

Study ID: NCT03509545
Lead sponsor: Sarfez Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Apr 26, 2018
Start date: Jun 30, 2021
Primary completion: Jun 30, 2022
Completion: Jun 30, 2022
Last update: Apr 24, 2026

Study contacts

Anil K, MD

principal investigator · Syngene

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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