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Doxazosin and Ramipril in Hypertension (DoRa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02901977
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Kahan, Karolinska Institutet

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACE inhibitor
Ramipril tablets 10 mg od for 12 weeks
Drug: Ramipril
Antihypertensive therapy
Other Name: Tiratec

Active Comparator: Alpha receptor blocker
Doxazosin tablets 8 mg od for 12 weeks
Drug: Doxazosin
Antihypertensive therapy
Other Name: Alfadil ,Cardura




Primary Outcome Measures :
  1. Thrombin generation [ Time Frame: 12 weeks ]
    Thrombin-Antithrombin complex (TAT)

  2. Endothelial function [ Time Frame: 12 weeks ]
    Forearm post-ischemic flow mediated dilatation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901977


Locations
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Sweden
Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory
Stockholm, Sweden, SE-182 88
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Thomas Kahan, MD Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Kahan, Principal investigator, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02901977    
Other Study ID Numbers: 2007-000631-25
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Thomas Kahan, Karolinska Institutet:
Hypertension
Blood pressure
Hemostasis
Endothelial function
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Ramipril
Doxazosin
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs