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

NCT ID: NCT03509545

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2022-06-30

Brief Summary

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

Detailed Description

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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

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Body Weight Changes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CHF Patients: ER Torsemide 40 mg

CHF patients will be given 40 mg ER Torsemide

Group Type EXPERIMENTAL

CHF Patients: ER Torsemide 40 mg

Intervention Type DRUG

ER Torsemide 40mg given once daily to CHF patients

CHF Patients: Furosemide 40 mg

CHF patients are on 40 mg of Furosemide

Group Type ACTIVE_COMPARATOR

CHF Patients: Furosemide 40 mg

Intervention Type DRUG

Stable CHF patients taking twice-daily 40 mg Furosemide

Interventions

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CHF Patients: ER Torsemide 40 mg

ER Torsemide 40mg given once daily to CHF patients

Intervention Type DRUG

CHF Patients: Furosemide 40 mg

Stable CHF patients taking twice-daily 40 mg Furosemide

Intervention Type DRUG

Other Intervention Names

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Demadex Lasix

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sarfez Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anil K, MD

Role: PRINCIPAL_INVESTIGATOR

Syngene

Locations

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Syngene International

Bangalore, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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CLCD-075-17

Identifier Type: -

Identifier Source: org_study_id

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