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

Primary Purpose

Body Weight Changes

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
CHF Patients: ER Torsemide 40 mg
CHF Patients: Furosemide 40 mg
Sponsored by
Sarfez Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Weight Changes focused on measuring natriuresis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Syngene InternationalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CHF Patients: ER Torsemide 40 mg

CHF Patients: Furosemide 40 mg

Arm Description

CHF patients will be given 40 mg ER Torsemide

CHF patients are on 40 mg of Furosemide

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in body weight
Body weight changes will be compared between the two arms

Full Information

First Posted
April 17, 2018
Last Updated
January 18, 2020
Sponsor
Sarfez Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03509545
Brief Title
Comparison of Once Daily 40 mg Torsemide With Twice-daily 40 mg Furosemide
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2021 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sarfez Pharmaceuticals, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes
Keywords
natriuresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CHF Patients: ER Torsemide 40 mg
Arm Type
Experimental
Arm Description
CHF patients will be given 40 mg ER Torsemide
Arm Title
CHF Patients: Furosemide 40 mg
Arm Type
Active Comparator
Arm Description
CHF patients are on 40 mg of Furosemide
Intervention Type
Drug
Intervention Name(s)
CHF Patients: ER Torsemide 40 mg
Other Intervention Name(s)
Demadex
Intervention Description
ER Torsemide 40mg given once daily to CHF patients
Intervention Type
Drug
Intervention Name(s)
CHF Patients: Furosemide 40 mg
Other Intervention Name(s)
Lasix
Intervention Description
Stable CHF patients taking twice-daily 40 mg Furosemide
Primary Outcome Measure Information:
Title
change in 24-hour sodium excretion compared to baseline
Description
the difference in 24 hour sodium excretion between ER Torsemide and Furosemide
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Changes in body weight
Description
Body weight changes will be compared between the two arms
Time Frame
2 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaya Patel, MS
Phone
+91 8028082838
Email
jaya.patel@syngeneint.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil K, MD
Organizational Affiliation
Syngene International
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syngene International
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560099
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaya Patel, MS
Phone
+91 8028082838
Email
jaya.patel@syngeneintl.com

12. IPD Sharing Statement

Learn more about this trial

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

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