Doxazosin and Ramipril in Hypertension

Hypertension Clinical Trial

— DoRa  

Official title:

On the Antithrombotic Effects of Doxazosin and Ramipril in Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901977
• Other study ID #: 2007-000631-25
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2016
• Last updated: September 10, 2016
• Start date: March 2011
• Est. completion date: April 2015

Study information

• Verified date: September 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Ramipril
Antihypertensive therapy
• Doxazosin
Antihypertensive therapy

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombin generation	Thrombin-Antithrombin complex (TAT)	12 weeks	No
Primary	Endothelial function	Forearm post-ischemic flow mediated dilatation	12 weeks	No