HypertensionPhase 4Low BP ViennaNCT02377661
Lowering Blood Pressure in Primary Care in Vienna
A Phase 4 study testing Olmesartan medoxomil, amlodipine, hydrochlorothiazide in people with Hypertension, run by Wilhelminenspital Vienna at 1 site in Austria.
Trial summary
The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance blood pressure control in primary care by introducing a standardised and simplified titration regime with single pill combinations (SPC), comprising an angiotensin receptor blocker, calcium channel blocker and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Olmesartan medoxomil, amlodipine, hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2015to 30 May 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- office blood pressure ≥ 140/90 mmHg
- ACE inhibitor intolerance (experimental arm)
Who cannot join
- Malignant disease with life expectancy < 6 months
- Women of childbearing potential (ICH definition) or breastfeeding
- Contraindications or allergies against olmesartan, amlodipine or hydrochlorothiazide (experimental arm)
- Chronic kidney disease grade IV or V (eGFR < 30 ml/min)
- Recent myocardial infarction or stroke within the preceding 3 months
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance blood pressure control in primary care by introducing a standardised and simplified titration regime with single pill combinations (SPC), comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.
Read the detailed description
Rationale Hypertension is the single largest contributor to mortality worldwide, accounting for 13% of deaths globally. Approximately 30% of the adult population suffer from hypertension and of those diagnosed and treated, only 30-50% have adequately controlled blood pressure. At present, the importance of hypertension as fundamental risk factors is inadequately addressed among many patients and physicians.
Design The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance blood pressure control in primary care by introducing a standardised and simplified titration regime with single pill combinations (SPC), comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.
The trial will randomise 42 family doctors or resident specialists for internal medicine (enrolling 840 patients with treated or untreated hypertension) to either experimental care or standard care for hypertension, latter according to the 2013 European Society of Cardiology Guidelines for the Management of Arterial Hypertension.
Practitioners randomised to experimental care will up-titrate antihypertensive therapy with SPCs in 4-week intervals if the target blood pressure of < 140/90 mmHg is not reached at the respective follow-up (Figure 1).
Study Outcomes The primary efficacy endpoint will be the proportion of patients achieving the target office blood pressure after 6 months of follow-up. The main secondary endpoint will be the improvement of 24h ambulatory blood pressure (ABPM) profile, measured at inclusion and after 6 months of follow-up.
Safety assessments include the evaluation of treatment emergent adverse events, particularly hospitalisation, worsening of renal function, peripheral oedema and hypotension.
- Conditions
- Hypertension
- Being tested
- Olmesartan medoxomil, amlodipine, hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olmesartan medoxomil, amlodipine, hydrochlorothiazideDrug
Up-titration of antihypertensive therapy with single pill combinations (comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide) in 4-week intervals if the target blood pressure of < 140/90 mmHg is not reached at the respective follow-up
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Treatment of hypertension according to current guidelines |
| Experimental Care | Experimental | Treatment of hypertension using a standardised and simplified titration regime with single pill combinations, comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide. Receives: Drug: Olmesartan medoxomil, amlodipine, hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of the target office blood pressure (< 140/90 mmHg)
Proportion of patients achieving the target office blood pressure of 140/90 mmHg
Measured: 6 months
Achievement of the target systolic office blood pressure (< 140 mmHg)
Proportion of patients achieving the target systolic office blood pressure of 140 mmHg
Measured: 6 months
Achievement of the target diastolic office blood pressure (< 90 mmHg)
Proportion of patients achieving the target diastolic office blood pressure of 90 mmHg
Measured: 6 months
Secondary outcomes (6)
Achievement of the target average 24h systolic ambulatory blood pressure (< 130 mmHg)
Average 24h systolic ambulatory blood pressure reading below 130 mmHg
Measured: 6 months
Achievement of the target average 24h diastolic ambulatory blood pressure (< 80 mmHg)
Average 24h diastolic ambulatory blood pressure reading below 80 mmHg
Measured: 6 months
Achievement of the target average daytime systolic ambulatory blood pressure (< 135 mmHg)
Average daytime systolic ambulatory blood pressure reading below 135 mmHg
Measured: 6 months
Achievement of the target average nighttime systolic ambulatory blood pressure (< 120 mmHg)
Average nighttime systolic ambulatory blood pressure reading below 120 mmHg
Measured: 6 months
Achievement of the target average daytime diastolic ambulatory blood pressure (< 85 mmHg)
Average daytime diastolic ambulatory blood pressure reading below 85 mmHg
Measured: 6 months
Achievement of the target average nighttime diastolic ambulatory blood pressure (< 70 mmHg)
Average nighttime diastolic ambulatory blood pressure reading below 70 mmHg
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilhelminenspital Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology, Ludwig Boltzmann Institute for Cardiovascular Research
- Responsible party
- Principal investigator, Thomas Weiss, MD, PhD, Wilhelminenspital Vienna
- Investigators
- Thomas W Weiss, MD, PhD, Principal investigator, 3rd Medical Department, Cardiology and Intensive Care Medicine Wilhelminenhospital, 1160 Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377661
- Sponsor's protocol ID
- V1-19012014
- Acronym
- Low BP Vienna
- Status last verified
- Aug 2017
- First submitted
- 16 Feb 2015
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rohla M, Tscharre M, Huber K, Weiss TW. Lowering blood pressure in primary care in Vienna (LOW-BP-VIENNA) : A cluster-randomized trial. Wien Klin Wochenschr. 2018 Dec;130(23-24):698-706. doi: 10.1007/s00508-018-1374-4. Epub 2018 Aug 15.
PubMed 30112584
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lowering Blood Pressure in Primary Care in Vienna
- ClinicalTrials.gov ID
- NCT02377661
- Acronym / sponsor ID
- Low BP Vienna / V1-19012014
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Wilhelminenspital ViennaUniversity, hospital or other
- Collaborators
- Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology, Ludwig Boltzmann Institute for Cardiovascular Research
- Study start
- Mar 2015 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 3 Mar 2015 (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.
The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance blood pressure control in primary care by introducing a standardised and simplified titration regime with single pill combinations (SPC), comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.
Detailed description
Rationale Hypertension is the single largest contributor to mortality worldwide, accounting for 13% of deaths globally. Approximately 30% of the adult population suffer from hypertension and of those diagnosed and treated, only 30-50% have adequately controlled blood pressure. At present, the importance of hypertension as fundamental risk factors is inadequately addressed among many patients and physicians.
Design The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance blood pressure control in primary care by introducing a standardised and simplified titration regime with single pill combinations (SPC), comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.
The trial will randomise 42 family doctors or resident specialists for internal medicine (enrolling 840 patients with treated or untreated hypertension) to either experimental care or standard care for hypertension, latter according to the 2013 European Society of Cardiology Guidelines for the Management of Arterial Hypertension.
Practitioners randomised to experimental care will up-titrate antihypertensive therapy with SPCs in 4-week intervals if the target blood pressure of < 140/90 mmHg is not reached at the respective follow-up (Figure 1).
Study Outcomes The primary efficacy endpoint will be the proportion of patients achieving the target office blood pressure after 6 months of follow-up. The main secondary endpoint will be the improvement of 24h ambulatory blood pressure (ABPM) profile, measured at inclusion and after 6 months of follow-up.
Safety assessments include the evaluation of treatment emergent adverse events, particularly hospitalisation, worsening of renal function, peripheral oedema and hypotension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Treatment of hypertension according to current guidelines |
| Experimental Care | Experimental | Drug: Olmesartan medoxomil, amlodipine, hydrochlorothiazideTreatment of hypertension using a standardised and simplified titration regime with single pill combinations, comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- office blood pressure ≥ 140/90 mmHg
- ACE inhibitor intolerance (experimental arm)
Key exclusion criteria (6 listed)
- Malignant disease with life expectancy < 6 months
- Women of childbearing potential (ICH definition) or breastfeeding
- Contraindications or allergies against olmesartan, amlodipine or hydrochlorothiazide (experimental arm)
- Chronic kidney disease grade IV or V (eGFR < 30 ml/min)
- Recent myocardial infarction or stroke within the preceding 3 months
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 |
|---|---|---|
| Olmesartan medoxomil, amlodipine, hydrochlorothiazideUp-titration of antihypertensive therapy with single pill combinations (comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide) in 4-week intervals if the target blood pressure of < 140/90 mmHg is not reached at the respective follow-up | Drug | Experimental Care |
Primary outcome
Achievement of the target office blood pressure (< 140/90 mmHg)
Time frame: 6 months
Proportion of patients achieving the target office blood pressure of 140/90 mmHg
Achievement of the target systolic office blood pressure (< 140 mmHg)
Time frame: 6 months
Proportion of patients achieving the target systolic office blood pressure of 140 mmHg
Achievement of the target diastolic office blood pressure (< 90 mmHg)
Time frame: 6 months
Proportion of patients achieving the target diastolic office blood pressure of 90 mmHg
6 secondary outcomes
Achievement of the target average 24h systolic ambulatory blood pressure (< 130 mmHg)
Time frame: 6 months
Achievement of the target average 24h diastolic ambulatory blood pressure (< 80 mmHg)
Time frame: 6 months
Achievement of the target average daytime systolic ambulatory blood pressure (< 135 mmHg)
Time frame: 6 months
Achievement of the target average nighttime systolic ambulatory blood pressure (< 120 mmHg)
Time frame: 6 months
Achievement of the target average daytime diastolic ambulatory blood pressure (< 85 mmHg)
Time frame: 6 months
Achievement of the target average nighttime diastolic ambulatory blood pressure (< 70 mmHg)
Time frame: 6 months
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 18 Aug 2017.
- Derived from this study: PubMed 30112584Rohla M, Tscharre M, Huber K, Weiss TW. Lowering blood pressure in primary care in Vienna (LOW-BP-VIENNA) : A cluster-randomized trial. Wien Klin Wochenschr. 2018 Dec;130(23-24):698-706. doi: 10.1007/s00508-018-1374-4. Epub 2018 Aug 15.
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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 W Weiss, MD, PhD principal investigator
3rd Medical Department, Cardiology and Intensive Care Medicine Wilhelminenhospital, 1160 Vienna, Austria
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 Olmesartan medoxomil, amlodipine, hydrochlorothiazide in people with Hypertension, run by Wilhelminenspital Vienna at 1 site in Austria.
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 3 inclusion and 6 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 18 Aug 2017. 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 Austria. 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?
Achievement of the target office blood pressure (< 140/90 mmHg) (time frame: 6 months). The study lists 3 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 NCT02377661, which also lists 1 linked publication.
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 18 Aug 2017.