ESSENTIAL HYPERTENSION MedDRA version: 12.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Trade Name: Triatec
Pharmaceutical Form: Capsule*
CAS Number: 87333-19-5
Other descriptive name: RAMIPRIL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade
Sponsors
KAROLINSKA INSTITUTET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of either sex and above the age of 18 with mild-to-moderate essential hypertension. All subjects should be previously untreated or have had no antihypertensive or other drug therapy for at least a 4-week period. They can be included provided their blood pressure is >140 mm Hg systolic and/or >90 mm Hg diastolic. 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: Secondary hypertension is ruled out by physical examination and routine biochemical examinations. No absolute indications for use of the study drugs, or contraindications against the use of the study drugs should be present. Patients with blood pressures > 180/110 mm Hg will not be allowed to participate. No participation in other studies is allowed. Pregnancy and lactation are criteria for exclusion. Premenopausal women should use an established contraceptive method during the study. Patients with present or recent (within 6 months) malignant disorder or antitumoral treatment are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) Does antihypertensive therapy with doxazosin exhibit antithrombotic effects in patients with essential hypertension?;Secondary Objective: 1) Are the potential antithrombotic effects of doxazosin comparable to the effects of an ACE inhibitor? 2) Is there a relation between the antihypertensive effect and the antithrombotic effect of these antihypertensive agents, and is there a relation between vascular function and the blood pressure lowering effect? ;Primary end point(s): Thrombin generation in plasma by prothrombin fragment 1 and 2 (F1+2), and by thrombin-antithrombin complex (TAT). 1) Factor VII and von Willebrand factor in plasma, tPA antigen and activity, and plasmin activator inhibitor (PAI-1) in plasma, as markers of fibrinolysis, Hematocrit, leukocyte, platelet and erythrocyte counts, Serum lipids (total cholesterol, LDL, HDL, triglycerides). 2) Peripheral artery blood pressure and central aortic blood pressure 3) Endothelial function analysed with flow mediated vasodilatation, pulse wave analysis with beta-2 agonist stimulation, and microcirculatory techniques. | — |
Countries
Sweden
Outcome results
None listed