Doxazosin and Ramipril in Hypertension | NCT02901977

Studies
Doxazosin and Ramipril in Hypertension

NCT02901977

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Mar 4, 2025Actual

Enrollment

71Actual

Phase

Phase 4

Conditions

Hypertension

Interventions

Ramipril
Doxazosin

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Feb 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Sep 9, 2016

First Submission Date that Met QC Criteria

Sep 10, 2016

First Posted Date

Sep 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2025

Last Update Posted Date

Mar 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ramipril	Drug	Antihypertensive therapy	ACE inhibitor	Tiratec

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thrombin generation	Thrombin-Antithrombin complex (TAT)	12 weeks
Endothelial function	Forearm post-ischemic flow mediated dilatation	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Kahan, MD	Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory		Stockholm		SE-182 88	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30244381	Derived	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.
29389738	Derived

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D011224	Prazosin