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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR FUROSEMIDE

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505(b)(2) Clinical Trials for Furosemide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00409942 Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure. Completed Ferrer Internacional S.A. Phase 4 2007-03-01 Torasemide is a loop diuretic (pyridine-sulfonylurea)with a wide experience in the treatment of oedema associated to heart failure, kidney or liver disease and either in the treatment of arterial hypertension (alone or combined with other anti-hypertensive drugs). It has been developed a new formulation of Torasemide (Torasemide prolonged release). The aim of this trial is to study the effects of Torasemide prolonged released in comparison with furosemide, in the reduction of myocardial fibrosis in patients with chronic heart failure (Class II-IV of the New York Heart Association Classification.
New Formulation NCT01887379 Magnetic Marker Monitoring of Furosemide-containing Gastroretentive Formulation in Healthy Male Subjects (Fasting and Fed Conditions) Completed LTS Lohmann Therapie-Systeme AG Phase 1 2013-06-01 Furosemide is a diuretic drug, used in the treatment of oedematous states associated with cardiac, renal, and hepatic disorder, and may be effective in patients unresponsive to thiazide diuretics. Furosemide is also used in the treatment of hypertension. Absorption of furosemide from the gastrointestinal tract is fairly rapid; bioavailability is 60-70%, but variable and not predictable, with large intra- and inter-individual variability, and are influenced by dosage form, underlying diseases, and by the presence of food after oral administration. Data from animal model show that furosemide administered into the stomach is more rapidly absorbed than if is administered into the small intestine. To increase the residency of furosemide in the stomach after oral administration, a gastroretentive dosage form (GRDF) of furosemide has been developed. In the current study, the new formulation (30mg furosemide coated tablet) will be tested in healthy male subjects. Absorption will be characterised by an effective and safe imaging technique - Magnetic Marker Monitoring (MMM), based on Fe3O4 added to the drug product to generate magnetic signal that can be used for up to 12 h after furosemide administration to localize the medication in the gastrointestinal tract. Fe3O4 is frequently used as colouring pigment in medicinal products. It does not exhibit own pharmacodynamic activity and is considered as an inactive ingredient. In the current study, GRDF formulation of furosemide will be evaluated for: gastric residence as well as pharmacokinetic and pharmacodynamic characteristics under fasting and fed conditions. As part of the study, the subjects will be hospitalized for 1 day during each drug administration. The duration of the stay will depend on the intestinal behaviour of the investigational product.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Furosemide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000620 Action to Control Cardiovascular Risk in Diabetes (ACCORD) Completed Centers for Disease Control and Prevention Phase 3 1999-09-01 The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 Action to Control Cardiovascular Risk in Diabetes (ACCORD) Completed National Eye Institute (NEI) Phase 3 1999-09-01 The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 Action to Control Cardiovascular Risk in Diabetes (ACCORD) Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 1999-09-01 The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 Action to Control Cardiovascular Risk in Diabetes (ACCORD) Completed National Institute on Aging (NIA) Phase 3 1999-09-01 The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 Action to Control Cardiovascular Risk in Diabetes (ACCORD) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1999-09-01 The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00007592 Hypertension Screening and Treatment Program Completed VA Office of Research and Development N/A 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Furosemide

Condition Name

Condition Name for Furosemide
Intervention Trials
Heart Failure 25
Congestive Heart Failure 17
Healthy 11
Heart Failure, Congestive 7
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Condition MeSH

Condition MeSH for Furosemide
Intervention Trials
Heart Failure 68
Renal Insufficiency 13
Hypertension 11
Acute Kidney Injury 9
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Clinical Trial Locations for Furosemide

Trials by Country

Trials by Country for Furosemide
Location Trials
United States 193
Italy 32
Canada 18
Germany 17
Spain 13
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Trials by US State

Trials by US State for Furosemide
Location Trials
Ohio 14
California 13
Minnesota 12
Texas 11
Tennessee 9
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Clinical Trial Progress for Furosemide

Clinical Trial Phase

Clinical Trial Phase for Furosemide
Clinical Trial Phase Trials
Phase 4 49
Phase 3 30
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Furosemide
Clinical Trial Phase Trials
Completed 65
Recruiting 43
Not yet recruiting 34
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Clinical Trial Sponsors for Furosemide

Sponsor Name

Sponsor Name for Furosemide
Sponsor Trials
scPharmaceuticals, Inc. 7
Assistance Publique - Hôpitaux de Paris 5
Merck Sharp & Dohme Corp. 5
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Sponsor Type

Sponsor Type for Furosemide
Sponsor Trials
Other 186
Industry 69
NIH 15
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