Comparison of Once Daily 40 mg Torsemide With Twice-daily... | NCT03509545

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

NCT03509545

Sponsor

Sarfez Pharmaceuticals, Inc.

Status

Terminated

Last Update Posted

Apr 24, 2026Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Body Weight Changes

Interventions

CHF Patients: ER Torsemide 40 mg
CHF Patients: Furosemide 40 mg

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment issues

Expanded Access Info

Start Date

Jun 30, 2021Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Jun 30, 2022Actual

First Submitted Date

Apr 17, 2018

First Submission Date that Met QC Criteria

Apr 25, 2018

First Posted Date

Apr 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CHF Patients: ER Torsemide 40 mg	Experimental	CHF patients will be given 40 mg ER Torsemide	Drug: CHF Patients: ER Torsemide 40 mg
CHF Patients: Furosemide 40 mg	Active Comparator	CHF patients are on 40 mg of Furosemide	Drug: CHF Patients: Furosemide 40 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CHF Patients: ER Torsemide 40 mg	Drug	ER Torsemide 40mg given once daily to CHF patients	CHF Patients: ER Torsemide 40 mg

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anil K, MD	Syngene	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Syngene International		Bangalore	Karnataka	560099	India

Condition Browse Module

MeSH Terms

ID	Term
D001836	Body Weight Changes

Ancestor Terms

ID	Term
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077786	Torsemide
D005665	Furosemide

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457

Browse Leaves

Not provided

Browse Branches

Not provided