Investigator Initiated Randomized Open-label Comparative Study of Britomar (Prolonged Release Torasemide) and Diuver (Torasemide) to Assess Effects on Natriuresis and Central Hemodynamics.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02087332|
Recruitment Status : Unknown
Verified March 2014 by Society of Specialists in Heart Failure.
Recruitment status was: Not yet recruiting
First Posted : March 14, 2014
Last Update Posted : March 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Arterial Hypertension Chronic Heart Failure||Drug: Prolonged release Torasemide (Britomar) Drug: Torasemide (Diuver)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Open-label Comparative Study of Britomar (Prolonged Release Torasemide) and Diuver (Torasemide) to Assess Effects on Natriuresis and Central Hemodynamics in Patients With Arterial Hypertension and Chronic Heart Failure|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||May 2015|
Experimental: Prolonged release Torasemide (Britomar)
Prolonged release Torasemide (Britomar) - round, biconvex, white to off-white tablets debossed SN with one side. 1 tablet contains active substance - torasemide 5 or 10 mg and excipients - guar gum, maize starch, anhydrous colloidal silica, magnesium stearate, lactose.
Dosage scheme: per os, once a day, regardless of meals. The common starting dose in CHF - 10-20 mg once a day. If adequate diuretic effect is absent, the dose is increased approximately twofold up to adequate diuretic effect.
Drug: Prolonged release Torasemide (Britomar)
Active Comparator: Torasemide (Diuver)
Torasemide (Diuver) - white to off-white, round, biconvex tablets. 1 tablet contain active substance - torasemide 5 or 10 mg and excipients - lactose monohydrate, maize starch, sodium glycolate starch, anhydrous colloidal silica, magnesium stearate. Dosage scheme: per os, once a day, after meals. Therapeutic dose - 5 mg a day. If necessary, a dose may be increased up to 20 mg a day, in some cases - up to 40 mg.
Drug: Torasemide (Diuver)
- Inflammatory markers excretion [ Time Frame: 3 months ]15% or more increasing of the following Tamm-Horsfall protein, beta-2-microglobulin, osteoponin, TGF- β1 excretion in comperison with baseline level
- Daily sodium excretion [ Time Frame: 3 months ]Increasing of daily sodium excretion on 30% or more in comparison with baseline
- Augmentation index [ Time Frame: 3 months ]Decreasing of augmentation index on 30 or more percents in comparison with baseline level
- Albuminuria [ Time Frame: 3 months ]Appearance of albuminuria of any stage or increasing of albuminuria level in case of existing albuminuria at the baseline. (measured by dipstick)
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): NCT02087332
|Contact: Grigory P Arutyunov, Prof||007(495)email@example.com|
|Principal Investigator:||Grigory P Arutyunov, Prof||Russian Society for Heart Failure|