THE ANTITTHROMBOTIC EFFECTS OF DOXAZOSIN AND RAMIPRIL IN ESSENTIAL HYPERTENSION

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-000631-25-SE
• Date of registration: 29/04/2010
• Prospective Registration: Yes
• Primary sponsor: KAROLINSKA INSTITUTET
• Public title: THE ANTITTHROMBOTIC EFFECTS OF DOXAZOSIN AND RAMIPRIL IN ESSENTIAL HYPERTENSION
• Scientific title: THE ANTITTHROMBOTIC EFFECTS OF DOXAZOSIN AND RAMIPRIL IN ESSENTIAL HYPERTENSION
• Date of first enrolment: 08/06/2010
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000631-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Sweden

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

ESSENTIAL HYPERTENSION
MedDRA version: 12.1 Level: LLT Classification code 10015488 Term: Essential hypertension

Intervention(s)

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 Name: Doxazosin
Pharmaceutical Form: Capsule*
INN or Proposed INN: DOXAZOSIN
CAS Number: 74191858
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-

Primary Outcome(s)

Main Objective: 1) Does antihypertensive therapy with doxazosin exhibit antithrombotic effects in patients with essential hypertension?

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.

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?

Secondary ID(s)

2007-000631-25