Body Weight ChangesPhase 1NCT03509545
Comparison of Once Daily 40 mg Torsemide With Twice-daily 40 mg Furosemide
A Phase 1 study testing CHF Patients: ER Torsemide 40 mg and CHF Patients: Furosemide 40 mg in people with Body Weight Changes, run by Sarfez Pharmaceuticals, Inc. at 1 site in India.
Trial summary
To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice daily Furosemide on 24-hour sodium excretion. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- CHF Patients: ER Torsemide 40 mg and CHF Patients: Furosemide 40 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 30 Jun 2021to 30 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either gender over 18 years of age with clinical diagnosis of CHF and on a stable dose of 40 mg Furosemide.
Who cannot join
- Requirement for any other diuretic, history of cardiac dysrhythmia, other concurrent cardiovascular illness.
Trial locations and contacts
1 site in 1 country.
About this study
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
To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice daily Furosemide on 24-hour sodium excretion.
Read the 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.
- Conditions
- Body Weight Changes
- Being tested
- CHF Patients: ER Torsemide 40 mg, CHF Patients: Furosemide 40 mg
- Keywords
- natriuresis
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF Patients: ER Torsemide 40 mgDrug
Also called Demadex
ER Torsemide 40mg given once daily to CHF patients
CHF Patients: Furosemide 40 mgDrug
Also called Lasix
Stable CHF patients taking twice-daily 40 mg Furosemide
| Study group | Role | What they receive |
|---|---|---|
| CHF Patients: ER Torsemide 40 mg | Experimental | CHF patients will be given 40 mg ER Torsemide Receives: Drug: CHF Patients: ER Torsemide 40 mg |
| CHF Patients: Furosemide 40 mg | Active comparator | CHF patients are on 40 mg of Furosemide Receives: Drug: CHF Patients: Furosemide 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in 24-hour sodium excretion compared to baseline
the difference in 24 hour sodium excretion between ER Torsemide and Furosemide
Measured: 24 hours
Secondary outcomes (1)
Changes in body weight
Body weight changes will be compared between the two arms
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start30 Jun 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarfez Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anil K, MD, Principal investigator, Syngene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509545
- Sponsor's protocol ID
- CLCD-075-17
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2018
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03509545
- Acronym / sponsor ID
- CLCD-075-17
- Conditions
- Body Weight Changes
- Keywords
- natriuresis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment issues
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sarfez Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHF Patients: ER Torsemide 40 mg | Experimental | Drug: CHF Patients: ER Torsemide 40 mgCHF patients will be given 40 mg ER Torsemide |
| CHF Patients: Furosemide 40 mg | Active comparator | Drug: CHF Patients: Furosemide 40 mgCHF patients are on 40 mg of Furosemide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of either gender over 18 years of age with clinical diagnosis of CHF and on a stable dose of 40 mg Furosemide.
Key exclusion criteria (1 listed)
- Requirement for any other diuretic, history of cardiac dysrhythmia, other concurrent cardiovascular illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHF Patients: ER Torsemide 40 mgAlso: DemadexER Torsemide 40mg given once daily to CHF patients | Drug | CHF Patients: ER Torsemide 40 mg |
| CHF Patients: Furosemide 40 mgAlso: LasixStable CHF patients taking twice-daily 40 mg Furosemide | Drug | CHF Patients: Furosemide 40 mg |
Primary outcome
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
1 secondary outcome
Changes in body weight
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil K, MD principal investigator
Syngene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHF Patients: ER Torsemide 40 mg and CHF Patients: Furosemide 40 mg in people with Body Weight Changes, run by Sarfez Pharmaceuticals, Inc. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in 24-hour sodium excretion compared to baseline (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.