Doxazosin and Ramipril in Hypertension

NCT ID: NCT02901977

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ACE inhibitor

Ramipril tablets 10 mg od for 12 weeks

Group Type EXPERIMENTAL

Ramipril

Intervention Type DRUG

Antihypertensive therapy

Alpha receptor blocker

Doxazosin tablets 8 mg od for 12 weeks

Group Type ACTIVE_COMPARATOR

Doxazosin

Intervention Type DRUG

Antihypertensive therapy

Interventions

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Ramipril

Antihypertensive therapy

Intervention Type DRUG

Doxazosin

Antihypertensive therapy

Intervention Type DRUG

Other Intervention Names

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Tiratec Alfadil ,Cardura

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Thomas Kahan

Principal investigator, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Kahan, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

Locations

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Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Jekell A, Kalani M, Kahan T. The interrelation of endothelial function and microvascular reactivity in different vascular beds, and risk assessment in hypertension: results from the Doxazosin-ramipril study. Heart Vessels. 2019 Mar;34(3):484-495. doi: 10.1007/s00380-018-1265-7. Epub 2018 Sep 22.

Reference Type DERIVED
PMID: 30244381 (View on PubMed)

Ekholm M, Jekell A, Wallen NH, Gigante B, Kahan T. Effects of Angiotensin-Converting Enzyme Inhibition and Alpha 1-Adrenergic Receptor Blockade on Inflammation and Hemostasis in Human Hypertension. J Cardiovasc Pharmacol. 2018 Apr;71(4):240-247. doi: 10.1097/FJC.0000000000000565.

Reference Type DERIVED
PMID: 29389738 (View on PubMed)

Jekell A, Kahan T. The usefulness of a single arm cuff oscillometric method (Arteriograph) to assess changes in central aortic blood pressure and arterial stiffness by antihypertensive treatment: results from the Doxazosin-Ramipril Study. Blood Press. 2018 Apr;27(2):88-98. doi: 10.1080/08037051.2017.1394791. Epub 2017 Oct 26.

Reference Type DERIVED
PMID: 29073803 (View on PubMed)

Jekell A, Kalani M, Kahan T. The effects of alpha 1-adrenoceptor blockade and angiotensin converting enzyme inhibition on central and brachial blood pressure and vascular reactivity: the doxazosin-ramipril study. Heart Vessels. 2017 Jun;32(6):674-684. doi: 10.1007/s00380-016-0924-9. Epub 2016 Nov 24.

Reference Type DERIVED
PMID: 27885499 (View on PubMed)

Other Identifiers

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2007-000631-25

Identifier Type: -

Identifier Source: org_study_id

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