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Rostafuroxin

Phase 2

Hypertension | Small molecule | Cardiovascular |Windtree Therapeutics, Inc.|Last Updated: Feb 21, 2023

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

Rostafuroxin · 1 trial · 1 indication

Phase 2 1
NCT03217825Antihypertensive Effect of Different Doses of Rostafuroxin in Comparison With LosartanHypertension
COMPLETED240 Analytics
PHASE2COMPLETED
Antihypertensive Effect of Different Doses of Rostafuroxin in Comparison With Losartan
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Systolic Blood Pressure
Week 9 of treatment versus baseline

Automated sitting and standing SBP and DBP will be recorded by physician at baseline (two visits) and at week 2, 5 and 9 of treatement. sitting: after the patient has rested for at least 10 minutes in a quiet room. There are five consecutive sitting BP readings with a 30 to 60 seconds interval between the readings; the mean of the last three sitting BP will be used.

Secondary Endpoints

Diastolic blood pressure
Baseline (two visits) and then at week 2, 5 and 9 of treatment
Trough-to-peak ratio on Systolic Blood Pressure
Throughout 24 hours ABPM
Number of participants with adverse events
throughout all the study period and follow-up (30 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Rostafuroxin 6 micrograms capsulesEXPERIMENTAL1 capsule of ROSTAFUROXIN (6 micrograms) once a day before breakfast.
Rostafuroxin 50 micrograms capsulesEXPERIMENTAL1 capsule of ROSTAFUROXIN (50 micrograms) once a day before breakfast.
Rostafuroxin 500 microgramsEXPERIMENTAL1 capsule of ROSTAFUROXIN (500 micrograms) once a day before breakfast.
Losartan 50 mg encapsulatedACTIVE_COMPARATOR1 capsule containing one cpr of Losartan 50 mg once a day before breakfast.

Interventions

NameTypeDescription
RostafuroxinDRUGThis is a potent, selective and safe inhibitor of this altered mechanism and has been proved to be effective in reducing blood pressure levels in Adducin mutated rat strains and in chronic Ouabain infused rat model.
LosartanDRUGCOZAAR (losartan potassium) is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a nonpeptide molecule, is chemically described as 2-butyl-4-chloro-1-\[p-(o-1H-tetrazol-5-ylphenyl)benzyl\]imidazole- 5-methanol monopotassium salt.
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Eligibility Criteria

Age Range25 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Signature of a written informed consent, included informed consent on genotype analysis. * Naive hypertensive patient (new diagnosed patient, never treated before). * Documented mild to moderate arterial hypertension: SBP comprised between 140 and 169 mmHg and DBP between 85 a...

Countries:Taiwan
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Frequently asked questions about Rostafuroxin

What is Rostafuroxin used for?

Rostafuroxin is an investigational small molecule being developed for the treatment of hypertension. It is currently in Phase 2 clinical development and has been studied in a completed trial in Taiwan. The drug is not yet approved and remains under investigation for its antihypertensive effects.

Who makes Rostafuroxin?

Rostafuroxin is being developed by Windtree Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol WINT. The company is conducting clinical research on this small molecule for the treatment of hypertension.

What phase is Rostafuroxin in?

Rostafuroxin is in Phase 2 clinical development. It has completed one Phase 2 trial, and it is not yet approved by regulatory authorities. The drug remains investigational and is being studied for its potential use in treating hypertension.

What clinical trials is Rostafuroxin in?

Rostafuroxin has been studied in one completed Phase 2 clinical trial with the identifier NCT03217825. This trial, titled "Antihypertensive Effect of Different Doses of Rostafuroxin in Comparison With Losartan," enrolled 240 participants with hypertension in Taiwan. The study was randomized, double-blind, and active-controlled.

Is Rostafuroxin the same as Losartan?

No, Rostafuroxin is not the same as Losartan. Rostafuroxin is an investigational small molecule being developed by Windtree Therapeutics for hypertension, while Losartan is an approved angiotensin II receptor blocker used as an active comparator in the clinical trial. The trial compared different doses of Rostafuroxin against Losartan.