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NCT03509545 Clinical Trial

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

Body Weight Changes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03509545
Other study ID # CLCD-075-17
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 30, 2021
Est. completion date June 30, 2022

Study information
Verified date April 2024
Source Sarfez Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• CHF Patients: ER Torsemide 40 mg
ER Torsemide 40mg given once daily to CHF patients
• CHF Patients: Furosemide 40 mg
Stable CHF patients taking twice-daily 40 mg Furosemide

Locations
Country Name City State
India Syngene International Bangalore Karnataka

Sponsors (1)
Lead Sponsor Collaborator
Sarfez Pharmaceuticals, Inc.

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in 24-hour sodium excretion compared to baseline the difference in 24 hour sodium excretion between ER Torsemide and Furosemide 24 hours
Secondary Changes in body weight Body weight changes will be compared between the two arms 2 weeks
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