HypertensionPhase 4DoRaNCT02901977
Doxazosin and Ramipril in Hypertension
A Phase 4 study testing Ramipril and Doxazosin in people with Hypertension, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Ramipril and Doxazosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2011to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary mild-to-moderate hypertension
Who cannot join
- Pregnancy and lactation
- Recent (6 months) malignant disease or ongoing treatment for malignancy
- No absolute indication or contraindication for any of the study drugs
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory
Stockholm, SE-182 88
About this study
Official title: On the Antithrombotic Effects of Doxazosin and Ramipril in Essential Hypertension
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Ramipril, Doxazosin
- Keywords
- Hypertension, Blood pressure, Hemostasis, Endothelial function
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamiprilDrug
Also called Tiratec
Antihypertensive therapy
DoxazosinDrug
Also called Alfadil ,Cardura
Antihypertensive therapy
| Study group | Role | What they receive |
|---|---|---|
| ACE inhibitor | Experimental | Ramipril tablets 10 mg od for 12 weeks Receives: Drug: Ramipril |
| Alpha receptor blocker | Active comparator | Doxazosin tablets 8 mg od for 12 weeks Receives: Drug: Doxazosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombin generation
Thrombin-Antithrombin complex (TAT)
Measured: 12 weeks
Endothelial function
Forearm post-ischemic flow mediated dilatation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startMar 2011
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Kahan, Karolinska Institutet
- Investigators
- Thomas Kahan, MD, Principal investigator, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901977
- Sponsor's protocol ID
- 2007-000631-25
- Acronym
- DoRa
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2016
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30244381Ekholm 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.
PubMed 29389738Jekell 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.
PubMed 29073803Jekell 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.
PubMed 27885499
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On the Antithrombotic Effects of Doxazosin and Ramipril in Essential Hypertension
- ClinicalTrials.gov ID
- NCT02901977
- Acronym / sponsor ID
- DoRa / 2007-000631-25
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood pressure, Hemostasis, Endothelial function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACE inhibitor | Experimental | Drug: RamiprilRamipril tablets 10 mg od for 12 weeks |
| Alpha receptor blocker | Active comparator | Drug: DoxazosinDoxazosin tablets 8 mg od for 12 weeks |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary mild-to-moderate hypertension
Key exclusion criteria (3 listed)
- Pregnancy and lactation
- Recent (6 months) malignant disease or ongoing treatment for malignancy
- No absolute indication or contraindication for any of the study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamiprilAlso: TiratecAntihypertensive therapy | Drug | ACE inhibitor |
| DoxazosinAlso: Alfadil ,CarduraAntihypertensive therapy | Drug | Alpha receptor blocker |
Primary outcome
Thrombin generation
Time frame: 12 weeks
Thrombin-Antithrombin complex (TAT)
Endothelial function
Time frame: 12 weeks
Forearm post-ischemic flow mediated dilatation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Derived from this study: PubMed 30244381Jekell 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.
- Derived from this study: PubMed 29389738Ekholm 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.
- Derived from this study: PubMed 29073803Jekell 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.
- Derived from this study: PubMed 27885499Jekell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kahan, MD principal investigator
Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramipril and Doxazosin in people with Hypertension, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombin generation (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02901977, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.