Hypertension
Conditions
Interventions
Product Name: SLV306
Pharmaceutical Form: Tablet
Current Sponsor code: SLV306
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placeb
Sponsors
Solvay Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria at screening: 1.Male or female patients =18 with hypertension. Females must be without childbearing potential. 2.Documented history of mild to moderate hypertension. 3.Sitting office diastolic blood pressure = 109 mmHg. Inclusion criteria at baseline: Sitting office diastolic blood pressure = 90 mmHg and = 109 mmHg Sitting office systolic blood pressure = 140 mmHg and = 179 mmHg Mean 24-ABPM day-time diastolic blood pressure = 85 mmHg 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
Exclusion criteria
Exclusion criteria: 1.Any woman of child-bearing potential who is pregnant, lactating, or not using a medically approved contraceptive method for at least 3 months prior to Visit 1. 2.Evidence of any respiratory, urogenital, gastrointestinal / hepatic, hematological / immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic / connective tissue, musculoskeletal, metabolic / nutritional, endocrine, neurologic / psychiatric diseases, allergy, major surgery or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which might limit participation in or completion of the study. 3.Concomitant use of other investigational drugs 4.Severe allergy or any history of severe abnormal drug reaction to amlodipine 5.Previous participation in any study with SLV306, including previous participation in this study. 6.Treatment for malignancy, except for basal cell carcinoma of the skin, within 12 months prior to Visit 1 7.Significant hepatic disease (two times the upper limit of normal ALT and AST) as measured at Visit 1. 8.Significantly reduced renal function (creatinine = 200 µmol/L) as measured at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the superiority of at least one dose of SLV306 compared to placebo on the change in office diastolic blood pressure (measured at trough in mmHg) from baseline in subjects with hypertension. ;Secondary Objective: 1.Change in trough office systolic blood pressure (SBP) from baseline to the end of treatment. 2.Change in mean SBP and DBP from baseline the end of treatment. 3.Change in mean daytime and night-time BP from baseline to the end of treatment. 4.Change in trough office SBP and DBP from baseline to the end of 4 and 12 weeks treatment. 5.Change in the neurohormones at trough: big ET-1, cyclic guanidine monophosphate (cGMP), angiotensin II and aldosterone from baseline to the end of the 4 and 12 weeks treatment period. 6.To determine plasma concentrations of SLV306 and its metabolite KC12615 as well as amlodipine. 7.To obtain safety and tolerability data: vital signs, physical examination, laboratory data, 12-lead ECG, adverse events and concomitant medication. ;Primary end point(s): Change in office diastolic blood pressure (measured at trough in mmHg) from baseline at the end of the treatment period in subjects with hypertension. | — |
Countries
Denmark, Estonia, Hungary, Latvia, Lithuania, Slovakia, United Kingdom
Outcome results
None listed