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

An Open Label,Crossover Study to Compare Once Daily Dose of 40 mg Torsemide Extended Release to Twice Daily of Furosemide on Natriuresis and Body Weight in Congestive Heart Failure (CHF) Patients Who Are on Stable Dose of Furosemide

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

Study Overview

• Status: Terminated
• Conditions: Body Weight Changes
• Intervention / Treatment: Drug: CHF Patients: ER Torsemide 40 mg; Drug: CHF Patients: Furosemide 40 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560099
      • Syngene International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHF Patients: ER Torsemide 40 mg; CHF patients will be given 40 mg ER Torsemide	Drug: CHF Patients: ER Torsemide 40 mg; ER Torsemide 40mg given once daily to CHF patients; Other Names: Demadex
Active Comparator: CHF Patients: Furosemide 40 mg; CHF patients are on 40 mg of Furosemide	Drug: CHF Patients: Furosemide 40 mg; Stable CHF patients taking twice-daily 40 mg Furosemide; Other Names: Lasix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in 24-hour sodium excretion compared to baseline	the difference in 24 hour sodium excretion between ER Torsemide and Furosemide	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body weight	Body weight changes will be compared between the two arms	2 weeks

Collaborators and Investigators

• Sponsor: Sarfez Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Anil K, MD, Syngene

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: natriuresis
• Additional Relevant MeSH Terms: Body Weight; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Body Weight Changes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amides; Aniline Compounds; Amines; Sulfonamides; Sulfanilamides; Sulfones; Torsemide; Furosemide
• Other Study ID Numbers: CLCD-075-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No