Inappropriate sinus tachycardia MedDRA version: 20.0 Level: LLT Classification code 10043083 Term: Tachycardia sinus System Organ Class: 100000004849
Conditions
Sponsors
Sinusventure LLC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients diagnosed with IST, 18 years of age or older Female subjects of childbearing potential agree to undergo pregnancy tests and to use a medically accepted, appropriate method of contraception (i.e. oral contraceptive steroids, intrauterine device, barrier method) Male subjects ready to use condom to prevent a pregnancy with a partner of childbearing potential during the study and the following month Documented sinus tachycardia during administration of bisoprolol monotherapy according to the following (at least one): Sinus tachycardia periods with HR ?100 beats/min during rest or after minimal physical stress Symptomatic mean resting HR ?90 beats/min during the daytime hours of 24-h Holter monitoring Rapid stable symptomatic increase in resting HR ?25 beats/min when moving from a supine to a standing position During Holter monitoring the mean HR above 100/min during alert state Patient complaints compatible with tachycardia: palpitation (paroxysmal or persistent) fatigue, exercise intolerance, orthostatic intolerance, vertigo, fainting or near fainting feeling, chest pain, dyspnea, anxiety Willingness to undergo a pre-study physical examination and preand post-study laboratory investigations Ability to comprehend and willingness to sign statements of informed consent (for the study) Ability, reliability and willingness to take the study compounds at the prescribed time points Taking bisoprolol (or placed on bisoprolol or at least 14 days before first treatment period). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Secondary sinus tachycardia (structural heart disease, hyperthyroidism, anaemia, infection, hypovolemia, pheochromocytoma, diabetes mellitus, or drug abuse) Paroxysmal orthostatic tachycardia syndrome (POTS) Any other cardiology or internal medicine disease which changes HR or necessitating enduring administration of cardioactive drugs, like sick sinus syndrome, diagnosis of orthostatic hypotension, antiarrhythmic therapy, renal or hepatic insufficiency History of, or current compulsive alcohol abuse (more than 10 drinks weekly); or regular exposure to other substances of abuse History of drug addiction, positive urine screen for drugs of abuse Donation or loss of blood equal to or exceeding 500 ml during 90 days before the first administration of study medication Positive testing for HIV, HBsAg and HCV Participation in another study with an experimental drug within at least 30 days (or within five elimination half-lives of the previous experimental drug, whichever is longer) before the first administration of study medication Pregnant women (positive pregnancy test) Lactating women Unwillingness or inability to comply with the study protocol or studyrelated procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of BGP-15 administration as compared to placebo in patients with inappropriate sinus tachycardia (IST) receiving betablocking treatment with bisoprolol. To assess the safety and tolerability of once daily 400 mg BGP-15 administration for 4 weeks. ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint of the study will be the proportion of subjects reaching at least 70% decrease of symptoms. The proportions obtained in the Placebo and the active treatment groups will be compared. ;Timepoint(s) of evaluation of this end point: Day 28 and day 63 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Hungary
Contacts
Public ContactGabor Bedocs
Sinusventure LLC.
Outcome results
None listed