DoRa: Doxazosin and Ramipril in Hypertension

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT02901977

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Ramipril Drug: Doxazosin	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

On the Antithrombotic Effects of Doxazosin and Ramipril in Essential Hypertension

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACE inhibitor Ramipril tablets 10 mg od for 12 weeks	Drug: Ramipril Antihypertensive therapy Other Names: Tiratec
Active Comparator: Alpha receptor blocker Doxazosin tablets 8 mg od for 12 weeks	Drug: Doxazosin Antihypertensive therapy Other Names: Alfadil ,Cardura

Arm

Intervention/Treatment

Experimental: ACE inhibitor

Ramipril tablets 10 mg od for 12 weeks

Drug: Ramipril

Antihypertensive therapy

Other Names:

Tiratec

Active Comparator: Alpha receptor blocker

Doxazosin tablets 8 mg od for 12 weeks

Drug: Doxazosin

Antihypertensive therapy

Other Names:

Alfadil ,Cardura

Outcome Measures

Primary Outcome Measures

Thrombin generation [12 weeks]
Thrombin-Antithrombin complex (TAT)
Endothelial function [12 weeks]
Forearm post-ischemic flow mediated dilatation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory	Stockholm		Sweden	SE-182 88

Sponsors and Collaborators

Karolinska Institutet

Investigators

Principal Investigator: Thomas Kahan, MD, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Kahan, Principal investigator, Professor, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT02901977

Other Study ID Numbers:

2007-000631-25

First Posted:

Sep 15, 2016

Last Update Posted:

Sep 15, 2016

Last Verified:

Sep 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Thomas Kahan, Principal investigator, Professor, Karolinska Institutet

Additional relevant MeSH terms:

Hypertension

Ramipril

Doxazosin

Study Results

No Results Posted as of Sep 15, 2016