HypertensionNCT02243566
Post-marketing Surveillance Study With MicardisPlus® in Treatment of Morning Hypertension (Self-monitored by Patient)
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
The purpose of the study was to examine the effect of six- to eight-week treatment with MicardisPlus® on blood pressure and the effect of patient self-monitoring on blood pressure control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- MicardisPlus®
- How many people
- 2,707 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Jan 2007
- Phase
- Observational
- 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
Study population: Outpatients with essential hypertension
Who may be able to join
- Age > 18 years
- Hypertension
Who cannot join
- Age < 18 years
About this study
Official title: Morning Hypertension and Patient Self-monitoring
The purpose of the study was to examine the effect of six- to eight-week treatment with MicardisPlus® on blood pressure and the effect of patient self-monitoring on blood pressure control. In addition, the post-marketing surveillance study offered the possibility to obtain information about the influence on different laboratory parameters during treatment with MicardisPlus® from an unselected patient group under office conditions
- Conditions
- Hypertension
- Being tested
- MicardisPlus®
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicardisPlus®Drug
Also called Telmisartan in combination with hydrochlorothiazide
| Study group | Role | What they receive |
|---|---|---|
| Essential hypertension | Not described Receives: Drug: MicardisPlus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in morning blood pressure (systolic and diastolic)
Measured: Pre-dose, up to 8 weeks after start of treatment
Changes from baseline in laboratory values
Measured: Pre-dose, up to 8 weeks after start of treatment
Investigator assessment of efficacy on a 5-point scale
Measured: Up to 8 weeks after start of treatment
Investigator assessment of influence on metabolism on a 3-point scale
Measured: Up to 8 weeks after start of treatment
Investigator assessment of tolerability on a 5-point scale
Measured: Up to 8 weeks after start of treatment
Number of patients with adverse events
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startApr 2006
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,707 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243566
- Sponsor's protocol ID
- 502.513
- Status last verified
- Sep 2014
- First submitted
- 16 Sep 2014
- Last updated
- 18 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morning Hypertension and Patient Self-monitoring
- ClinicalTrials.gov ID
- NCT02243566
- Acronym / sponsor ID
- 502.513
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,707 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jan 2007 (actual)
- First posted
- 18 Sep 2014 (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 purpose of the study was to examine the effect of six- to eight-week treatment with MicardisPlus® on blood pressure and the effect of patient self-monitoring on blood pressure control. In addition, the post-marketing surveillance study offered the possibility to obtain information about the influence on different laboratory parameters during treatment with MicardisPlus® from an unselected patient group under office conditions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Essential hypertension | – | Drug: MicardisPlus® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with essential hypertension
Key inclusion criteria (2 listed)
- Age > 18 years
- Hypertension
Key exclusion criteria (1 listed)
- Age < 18 years
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 |
|---|---|---|
| MicardisPlus®Also: Telmisartan in combination with hydrochlorothiazide | Drug | Essential hypertension |
Primary outcome
Changes in morning blood pressure (systolic and diastolic)
Time frame: Pre-dose, up to 8 weeks after start of treatment
Changes from baseline in laboratory values
Time frame: Pre-dose, up to 8 weeks after start of treatment
Investigator assessment of efficacy on a 5-point scale
Time frame: Up to 8 weeks after start of treatment
Investigator assessment of influence on metabolism on a 3-point scale
Time frame: Up to 8 weeks after start of treatment
Investigator assessment of tolerability on a 5-point scale
Time frame: Up to 8 weeks after start of treatment
Number of patients with adverse events
Time frame: Up to 8 weeks
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 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Boehringer Ingelheim.
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 2 inclusion and 1 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 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Changes in morning blood pressure (systolic and diastolic) (time frame: Pre-dose, up to 8 weeks after start of treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2014.