Study on the clinical efficacy of adjuvant BGP-15 treatment additional to beta-blocker bisoprolol in patients with inappropriate sinus tachycardia
- Conditions
- Inappropriate sinus tachycardiaMedDRA version: 20.0Level: LLTClassification code 10043083Term: Tachycardia sinusSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2020-003005-61-HU
- Lead Sponsor
- Sinusventure LLC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of BGP-15 administration as compared to placebo<br>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. <br>;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 Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable