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

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ClinicalTrials.gov Identifier: NCT03509545
Recruitment Status : Not yet recruiting
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Sarfez Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Body Weight Changes Drug: CHF Patients: ER Torsemide 40 mg Drug: CHF Patients: Furosemide 40 mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 17, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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 Name: 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 Name: Lasix




Primary Outcome Measures :
  1. change in 24-hour sodium excretion compared to baseline [ Time Frame: 24 hours ]
    the difference in 24 hour sodium excretion between ER Torsemide and Furosemide


Secondary Outcome Measures :
  1. Changes in body weight [ Time Frame: 2 weeks ]
    Body weight changes will be compared between the two arms



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509545


Contacts
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Contact: Jaya Patel, MS +91 8028082838 jaya.patel@syngeneint.com

Locations
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India
Syngene International Completed
Bangalore, Karnataka, India, 560099
Sponsors and Collaborators
Sarfez Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Anil K, MD Syngene International

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Responsible Party: Sarfez Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03509545     History of Changes
Other Study ID Numbers: CLCD-075-17
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

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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
Keywords provided by Sarfez Pharmaceuticals, Inc.:
natriuresis
Additional relevant MeSH terms:
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Furosemide
Body Weight
Body Weight Changes
Signs and Symptoms
Torsemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents