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.
- Conditions
- Hypertension
- Registration Number
- EUCTR2007-001668-62-DE
- Lead Sponsor
- Surface Logix, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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
method.
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
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
the study.
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
range.
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
drugs.
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
study.
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
the study.
24. Vulnerable individuals (e.g., persons kept in detention).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method