HypertensionPhase 4NCT00244660
Blood Pressure Reduction in Danish General Practice (BRIDGE)
A Phase 4 study testing Frequent blood pressure measurements and Education in people with Hypertension, run by Boehringer Ingelheim at 1 site in Denmark.
Trial summary
To investigate the effect on blood pressure (BP) control in hypertensive patients using a combination of frequent home - and 24-h ambulatory blood pressure measurement (ABPM) in a Danish general practice (GP) setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Frequent blood pressure measurements and Education
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2005to Jun 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: 18 years or more, informed consent obtained, essential hypertension, able to use a home blood pressure apparatus, can cooperate to ambulatory blood pressure measurement. Exclusion criteria: Pregnancy, hypertension secondary to another disorder.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect on blood pressure (BP) control in hypertensive patients using a combination of frequent home - and 24-h ambulatory blood pressure measurement (ABPM) in a Danish general practice (GP) setting.
Read the detailed description
Also the beneficial effect of optimal blood pressure (BP) control is well established, sub-optimal blood pressure control is still highly prevalent in the hypertensive population. The purpose of this study is to evaluate the effect of frequent home (HBPM)- and 24 hour (ABPM) blood pressure measurements to achieve BP control in patients with essential hypertension according to Danish Society of Hypertension Gudelines. The study will include 120 general practioners (GP) randomised to perform either usual BP control or intensive BP control. Before randomization, participating GPs will recruit each 10 patients to be followed over a period of 12 months. At baseline ABPM will be measured in all eligible patients. The result of the baseline ABPM will be blinded in the usual care group. Following this, usual care (control) physicians will perform BP control according to their usual standard. Physicians randomized to intensive care will control BP by the use of frequent HBPM and ABPM. According to a pre-specified scheme patients followed by intensive care physicians will measure HBP in the morning and in the evening at three consecutive days after 1, 2, 4, 8 and 10 months in the study. Patients will communicate the results of these measurements to the treating physician, who according to the result of the HBPM will decide what action to take. As a further aid, at 6 month patients in the intensive care group will have another APBM as part of the follow up to ensure 24 hour BP control. In both the usual- and intensive care group all treatment decisions is entirely up to the treating physician. No pre-specified treatment algorithm has to be followed and both non-pharmacological as well as any pharmacological tretment can be used to (optimize) BP control. Patients followed by intensive care will receive extended structured information about the importance of optimal BP control. As the primary endpoint is change in mean 24-hour ambulatory systolic and diastolic blood pressure patients in both groups will have a ABPM after 12 months. During the whole trial, participating physicians will keep a record of all measured BP (clinic BP, HBP and ABP), as well as all relevant blood- and urinary tests (lipids, glucose, albuminuria) taken during the study. Based on all available information, patients total risk score (Danish Society of Hypertension) will be calculated at baseline and after 12 months.
Study Hypothesis:
Blood pressure control according to the Danish Society of Hypertension Guidelines is better obtained by an intensive care regimen (frequent home- and ambulatory blood pressure measurement) compared to a usual care regimen (standard blood pressure control in Danish general practice).
Comparison(s):
Frequent home- and ambulatory blood pressure measurements versus standard care.
- Conditions
- Hypertension
- Being tested
- Frequent blood pressure measurements, Education
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequent blood pressure measurementsProcedure or surgery
EducationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean 24-hour (ambulatory) systolic and diastolic blood pressure after 12 months.
Secondary outcomes (1)
Change in clinic and home sysolic and diastolic blood pressure after 12 months, change in systolic and diastolic blood pressure the last 6 hours of the dosing interval (morning blood pressure) and change in over all risk score after 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startNov 2005
- Study completionJun 2007
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.
- More trials run by Boehringer IngelheimThe 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
- None (open label)
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Denmark A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244660
- Sponsor's protocol ID
- 502.504
- Status last verified
- Jan 2008
- First submitted
- 20 Oct 2005
- Last updated
- 21 Jan 2008
- Results posted
- No
Publications
Klarskov P, Bang LE, Schultz-Larsen P, Gregers Petersen H, Benee Olsen D, Berg RMG, Abrahamsen H, Wiinberg N. Intensive versus conventional blood pressure monitoring in a general practice population. The Blood Pressure Reduction in Danish General Practice trial: a randomized controlled parallel group trial. Fam Pract. 2018 Jul 23;35(4):433-439. doi: 10.1093/fampra/cmx106.
PubMed 29351658
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Reduction in Danish General Practice (BRIDGE)
- ClinicalTrials.gov ID
- NCT00244660
- Acronym / sponsor ID
- 502.504
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Jun 2007
- First posted
- 27 Oct 2005 (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.
To investigate the effect on blood pressure (BP) control in hypertensive patients using a combination of frequent home - and 24-h ambulatory blood pressure measurement (ABPM) in a Danish general practice (GP) setting.
Detailed description
Also the beneficial effect of optimal blood pressure (BP) control is well established, sub-optimal blood pressure control is still highly prevalent in the hypertensive population. The purpose of this study is to evaluate the effect of frequent home (HBPM)- and 24 hour (ABPM) blood pressure measurements to achieve BP control in patients with essential hypertension according to Danish Society of Hypertension Gudelines. The study will include 120 general practioners (GP) randomised to perform either usual BP control or intensive BP control. Before randomization, participating GPs will recruit each 10 patients to be followed over a period of 12 months. At baseline ABPM will be measured in all eligible patients. The result of the baseline ABPM will be blinded in the usual care group. Following this, usual care (control) physicians will perform BP control according to their usual standard. Physicians randomized to intensive care will control BP by the use of frequent HBPM and ABPM. According to a pre-specified scheme patients followed by intensive care physicians will measure HBP in the morning and in the evening at three consecutive days after 1, 2, 4, 8 and 10 months in the study. Patients will communicate the results of these measurements to the treating physician, who according to the result of the HBPM will decide what action to take. As a further aid, at 6 month patients in the intensive care group will have another APBM as part of the follow up to ensure 24 hour BP control. In both the usual- and intensive care group all treatment decisions is entirely up to the treating physician. No pre-specified treatment algorithm has to be followed and both non-pharmacological as well as any pharmacological tretment can be used to (optimize) BP control. Patients followed by intensive care will receive extended structured information about the importance of optimal BP control. As the primary endpoint is change in mean 24-hour ambulatory systolic and diastolic blood pressure patients in both groups will have a ABPM after 12 months. During the whole trial, participating physicians will keep a record of all measured BP (clinic BP, HBP and ABP), as well as all relevant blood- and urinary tests (lipids, glucose, albuminuria) taken during the study. Based on all available information, patients total risk score (Danish Society of Hypertension) will be calculated at baseline and after 12 months.
Study Hypothesis:
Blood pressure control according to the Danish Society of Hypertension Guidelines is better obtained by an intensive care regimen (frequent home- and ambulatory blood pressure measurement) compared to a usual care regimen (standard blood pressure control in Danish general practice).
Comparison(s):
Frequent home- and ambulatory blood pressure measurements versus standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Frequent blood pressure measurements | Procedure or surgery | – |
| Education | Behavioural | – |
Primary outcome
Change in mean 24-hour (ambulatory) systolic and diastolic blood pressure after 12 months.
1 secondary outcome
Change in clinic and home sysolic and diastolic blood pressure after 12 months, change in systolic and diastolic blood pressure the last 6 hours of the dosing interval (morning blood pressure) and change in over all risk score after 12 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 21 Jan 2008.
- Derived from this study: PubMed 29351658Klarskov P, Bang LE, Schultz-Larsen P, Gregers Petersen H, Benee Olsen D, Berg RMG, Abrahamsen H, Wiinberg N. Intensive versus conventional blood pressure monitoring in a general practice population. The Blood Pressure Reduction in Danish General Practice trial: a randomized controlled parallel group trial. Fam Pract. 2018 Jul 23;35(4):433-439. doi: 10.1093/fampra/cmx106.
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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.
Boehringer Ingelheim Study Coordinator study chair
B.I. Denmark A/S
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 Frequent blood pressure measurements and Education in people with Hypertension, run by Boehringer Ingelheim at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Jan 2008. 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 Denmark. 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?
Change in mean 24-hour (ambulatory) systolic and diastolic blood pressure after 12 months.. 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 NCT00244660, 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 21 Jan 2008.