Doxazosin and Ramipril in Hypertension (DoRa)

Karolinska Institute

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Doxazosin; Drug: Ramipril

Study type: Interventional

Funder types: Other

Identifiers

NCT02901977

2007-000631-25

Details and patient eligibility

About

Randomized double-blind parallel group study in patients with mild-to-moderate hypertension to evaluate the effects beyond the blood pressure lowering effect of treatment for 12 weeks with ramipril or doxazosin on hemostatic mechanisms and on endothelial function.

Full description

This study aims to answer the following questions: 1) Does antihypertensive therapy with doxazosin exhibit antithrombotic effects in patients with essential hypertension? 2) Are the potential antithrombotic effects of doxazosin different to the effects of an ACE inhibitor? 3) Is there a relation between the antihypertensive effect and the antithrombotic effect of these antihypertensive agents?

The co-primary outcomes are changes in endothelial function assessed by flow mediated vasodilatation, and in haemostatic function measured by the generation of thrombin-antithrombin complex.

Enrollment: 71 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary mild-to-moderate hypertension

Exclusion criteria

• Pregnancy and lactation
• Recent (6 months) malignant disease or ongoing treatment for malignancy
• No absolute indication or contraindication for any of the study drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 2 patient groups

ACE inhibitor

Experimental group

Description:

Ramipril tablets 10 mg od for 12 weeks

Treatment:

Drug: Ramipril

Alpha receptor blocker

Active Comparator group

Description:

Doxazosin tablets 8 mg od for 12 weeks

Treatment:

Drug: Doxazosin