A pilot Phase IIa randomised, double blind, placebo-controlled, crossover study to examine the safety, tolerability and pharmacodynamic effects on blood pressure of repeat oral doses of SLx-2101 5, 10 or 20 mg once daily for up to 14 days in patients with hypertension.

Surface Logix, Inc.0 个研究点目标入组 20 人开始时间: 2007年1月30日最近更新: 2019年11月25日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Surface Logix, Inc.
入组人数: 20

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•1. Males or females aged between 18 and 80 years, inclusive.
•Female subjects must be of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy.
•Male subjects must use a condom. Male partners of female subjects must use a condom/spermicide during sexual intercourse with females of childbearing potential in addition to the subject using a second form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if engaging in sexual intercourse. This criterion must be followed from the time of the first dose of study medication until 30 days after the last dose of study medication.
•2. Moderate to severe hypertension, defined as a DBP of > or =90 mmHg and < or =120 mmHg and SBP of > or =140 mmHg and < or =220 mmHg.
•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 alpha-blockers or medication known to affect BP except those allowed in the protocol.
•4. The subject has been a regular user of PDE5 inhibitors and/or is unable to refrain from using these agents for 5 days before and for the period of their participation in the study.
•5. The subject is receiving more than FOUR 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 range.
•8. Active pancreatitis.
•9. Abuse of alcohol, defined as a maximum weekly intake of greater than 28 units or an average daily intake of greater than 3 units for males or an average weekly intake of greater than 21 units or an average intake of greater than 2 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 drugs.
•12. History or presence of severe peripheral vascular disease, heart failure (NYHA type 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. Exposure to a new chemical entity within 3 months prior to the first dosing day.
•15. Participation in a trial with any drug within 30 days before the start of the study.
•16. The subject has a known significant history of non-compliance with prescribed medication.
•17. If participation in the study will result in the subjects having donated more than 500 mL blood (males) in the previous 6 months.
•18. Male subjects attempting to father a child during and up to 3 months after the study and female subjects attempting to become pregnant during and up to 3 months after the study.
•19. If in the Investigators opinion, the subject is unsuitable to participate in the study.

研究者

发起方

Surface Logix, Inc.

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