NCT02901977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
Last Updated

March 4, 2025

Status Verified

September 1, 2016

Enrollment Period

3.9 years

First QC Date

September 9, 2016

Last Update Submit

March 3, 2025

Conditions

Hypertension

Keywords

HypertensionBlood pressureHemostasisEndothelial function

Outcome Measures

Primary Outcomes (2)

  • Thrombin generation

    Thrombin-Antithrombin complex (TAT)

    12 weeks

  • Endothelial function

    Forearm post-ischemic flow mediated dilatation

    12 weeks

Study Arms (2)

ACE inhibitor

EXPERIMENTAL

Ramipril tablets 10 mg od for 12 weeks

Drug: Ramipril

Alpha receptor blocker

ACTIVE COMPARATOR

Doxazosin tablets 8 mg od for 12 weeks

Drug: Doxazosin

Interventions

RamiprilDRUG

Antihypertensive therapy

Also known as: Tiratec
ACE inhibitor
DoxazosinDRUG

Antihypertensive therapy

Also known as: Alfadil ,Cardura
Alpha receptor blocker

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary mild-to-moderate hypertension

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Stockholm, SE-182 88, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 30244381DERIVED

  • 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.

    PMID: 29389738DERIVED

  • 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.

    PMID: 29073803DERIVED

  • 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.

    PMID: 27885499DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

RamiprilDoxazosin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPrazosinQuinazolines

Study Officials

  • Thomas Kahan, MD

    Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Professor

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 15, 2016

Study Start

March 1, 2011

Primary Completion

February 1, 2015

Study Completion

April 1, 2015

Last Updated

March 4, 2025

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)