EUCTR2020-003005-61-HU进行中（未招募）1 期
A phase 2 study on the clinical efficacy of adjuvant BGP-15 treatment additional to beta-blocker bisoprolol in patients with inappropriate sinus tachycardia
Sinusventure LLC.0 个研究点目标入组 20 人开始时间: 2020年8月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients diagnosed with IST, 18 years of age or
- •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
- •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
- •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
排除标准
- •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
研究者
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