EUCTR2007-001668-62-DE进行中（未招募）不适用
A pilot Phase IIa, randomised, double blind, placebocontrolled, crossover study to examine the safety, tolerability and pharmacodynamic effects on blood pressure of repeat oral doses of SLx-2101 5 mg or 10 mg once daily for up to 14 days in patients with hypertension.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •1. Male or female subjects aged between 18 and 70 years, inclusive.
- •-Female subjects of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy, double oophorectomy or tubal ligation or postmenopausal defined as 12 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and oestradiol levels < 30 pg/mL or
- •- Females, who are of childbearing potential, must use adequate contraception with
- •double protection prior to and during the trial: double barrier methods (condom,
- •diaphragm, coil or intrauterine device (IUD,) in combination with spermicide) or
- •hormonal contraception (oral, depot or implants) in combination with a barrier
- •2. Moderate to severe hypertension, defined as a DBP of >90 mmHg and <110 mmHg
- •and a sustained SBP of >140 mmHg and < 180 mmHg or a sustained SBP of >140
- •mmHg and < 180 mmHg (ISH).
- •(In case of subject receiving antihypertensive agents a DBP ³85 mmHg and £110 mmHg
- •and a sustained SBP of ³130 mmHg and £180 mmHg or a sustained SBP of ³130
- •mmHg and £ 180 mmHg will be acceptable).
- •3. Body weight within a body mass index range of 18 – 32 kg/m2.
- •4. Able to provide written informed consent prior to the performance of any study
- •specific procedures.
- •5. A 12-lead ECG at the pre-study medical, which in the opinion of the Investigator, has
- •no abnormalities that will compromise safety in this study.
- •6. A negative pre-study urine drugs of abuse screen within 21 days of study start.
- •7. Available to complete all study measurements.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Past or present disease that is judged by the Investigator to have the potential to
- •interfere with the study procedures, compromise safety, or affect the pharmacodynamic evaluations.
- •2. The subject has a history of orthostatic hypotension, fainting spells or blackouts.
- •3. The subject is taking nitrates and/or alpha-blockers or medication known to affect
- •BP except those allowed in the protocol, please refer to Section 4.2.4 for permitted
- •and prohibited drugs)..
- •4. The subject has been a regular user of PDE-5 inhibitors and/or is unable to refrain
- •from using these agents for 5 days before and for the period of their participation in
- •5. The subject is receiving more than THREE antihypertensive agents.
- •6. The subject has malignant hypertension, primary hyperaldosteronism or secondary
- •hypertension.
- •7. Screening liver function tests exceeding 1.5 times the upper limit of the normal
- •8. Active pancreatitis.
- •9. Abuse of alcohol, defined as a average weekly intake of greater than 21 units for
- •males or 14 units for females (1 unit is equivalent to a half pint of beer or 1 measure
- •of spirits or 1 glass of wine).
- •10. A history of drug abuse.
- •11. History or presence of gastro-intestinal, hepatic or renal disease or other condition
- •known to interfere with the absorption, distribution, metabolism or excretion of
- •12. History or presence of severe peripheral vascular disease, coronary heart disease,
- •heart failure (New York Heart Association type II, III or IV), myocardial infarction
- •or cardiac surgery (in the last 12 months), hypertrophic obstructive cardiomyopathy,
- •aortic or mitral valve stenosis, stroke, PCTA in the last 6 months.
- •13. Known to be infected with the human immunodeficiency virus or hepatitis B or C.
- •14. The subject has an abnormal thyroid function test assessed by thyroid stimulating
- •hormone (TSH) levels at Screening.
- •15. Exposure to a new chemical entity within 3 months prior to the first dosing day.
- •16. Participation in a trial with any drug within 30 days before the start of the study.
- •17. The subject has a known significant history of non-compliance with prescribed
- •medication.
- •18. If participation in the study will result in the volunteer having donated more than
- •500 mL blood (males) in the previous 6 months.
- •19. Male subjects attempting to father a child during and up to 3 months after the study
- •Female subjects attempting to become pregnant during and up to 3 months after the
- •20. If in the Investigators opinion, the subject is unsuitable to participate in the study.
- •21. Inability to understand the protocol requirements, instructions and study-related
- •restrictions; the nature, scope and possible consequences of the study.
- •22. Unlikely to complete the study; e.g., uncooperative attitude, inability to return for
- •Follow-up Visits.
- •23. Subject is the Investigator or any sub-investigator, research assistant, pharmacist,
- •study coordinator, other staff, or relative thereof directly involved in the conduct of
- •24. Vulnerable individuals (e.g., persons kept in detention).
研究者
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