Hypertension MedDRA version: 9.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Interventions
Product Name: SLx-2101
Product Code: SLx-2101
Pharmaceutical Form: Capsule, hard
Current Sponsor code: SLx-2101
Concentration unit: mg m
Sponsors
Surface Logix, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Or 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 =140 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Period 1: To determine which dose of SLx-2101 (5 mg or 20 mg) to use in the repeat dose cross-over phase of the study (Period 2). Period 2: To determine the effect of SLx-2101 dosed for 14 days on placebo-corrected, office seated peripheral systolic and diastolic blood pressure. ; Secondary Objective: Period 1: nil Period 2: To determine the effect of SLx-2101 dosed for 14 days on placebo corrected, home monitored blood pressure. To explore the effect of repeat-dosing with SLx-2101 for 14 days on placebo-corrected central blood pressure and heart rate. To explore the effect of repeat-dosing with SLx-2101 for 14 days on placebo-corrected large elastic artery compliance. To explore the effect of repeat-dosing with SLx-2101 for 14 days on endothelium-dependent flow-mediated dilatation. To determine the safety and tolerability of repeat oral doses of SLx-2101 for 14 days in patients with hypertension. ; Primary end point(s): Period 1: Office seated peripheral systolic and diastolic blood pressure. Period 2: Office seated peripheral systolic and diastolic blood pressure. | — |
Countries
United Kingdom
Outcome results
None listed