HypertensionNCT00946829
Study of Hypertensive Population Under Treatment With Telmisartan in Real Clinical Conditions With the Goal to Control Early Morning Blood Pressure Rise
An observational study of Hypertension, run by Boehringer Ingelheim at 12 sites in 12 countries.
Trial summary
The aim of the observational study is to ascertain the degree of blood pressure control in the early-morning hours after 8 weeks of treatment with Telmisartan/Telmisartan+Hydrochlorothiazide and during 44 weeks of follow-up, in patients with hypertension using home blood pressure measurements. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- telmisartan
- How many people
- 18,299 participants
- Where
- 12 sitesin 12 countries
- Study dates
- Jan 2003to May 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- Patients with mild to moderate essential hypertension and whose medical condition make them eligible for treatment with Telmisartan/Telmisartan+HCTZ
Who cannot join
- Pre-menopausal women who had had no birth control, who are pregnant or nursing
- Patients with advanced hepatic impairment, advanced renal impairment or both
- Patients with functional class III or IV (NYHA) congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months
- Patients with any valvular disease with hemodynamic repercussion
- Patients receiving chronic administration of oral anticoagulants or digoxin
- Patients with known hypersensitivity to any component in the formulation of Micardis / MicardisPlus
Show all 9Show fewer
- Patients with previous history of angioedema associated with ACE inhibitors
- Patients with severe, uncontrolled hypertension or any form of secondary hypertension
- Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol
Trial locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
Belgium1 site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Canada1 site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Colombia1 site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Czechia1 site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Ecuador1 site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Indonesia1 site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Jordan1 site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Lebanon1 site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Mexico1 site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Turkey (Türkiye)1 site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Venezuela1 site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Yemen1 site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
About this study
Official title: Study of Hypertensive Population Under Treatment With Micardis in Real Clinical Conditions With the Goal to Control the Early Morning BP Rise
The aim of the observational study is to ascertain the degree of blood pressure control in the early-morning hours after 8 weeks of treatment with Telmisartan/Telmisartan+Hydrochlorothiazide and during 44 weeks of follow-up, in patients with hypertension using home blood pressure measurements.
- Conditions
- Hypertension
- Being tested
- telmisartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telmisartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean early morning systolic blood pressure, mean early morning diastolic blood pressure, and degree of control. (6:00 to 11:59), BP < 135/85 mmHg. (HBPM: mean of morning measurements).
Measured: 217 Weeks
Secondary outcomes (1)
Clinical control (office BP), response rates, reduction in office cuff systolic and diastolic BP. Office BP control criteria: BP < 140/90 mmHg. Pulse rate, pulse pressure, discontinuations and tolerability.
Measured: 217 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJan 2003
- Primary completionMay 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
- 18,299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946829
- Sponsor's protocol ID
- 502.425
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2009
- Last updated
- 5 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hypertensive Population Under Treatment With Micardis in Real Clinical Conditions With the Goal to Control the Early Morning BP Rise
- ClinicalTrials.gov ID
- NCT00946829
- Acronym / sponsor ID
- 502.425
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,299 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- May 2007 (actual)
- First posted
- 27 Jul 2009 (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 the observational study is to ascertain the degree of blood pressure control in the early-morning hours after 8 weeks of treatment with Telmisartan/Telmisartan+Hydrochlorothiazide and during 44 weeks of follow-up, in patients with hypertension using home blood pressure measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (1 listed)
- Patients with mild to moderate essential hypertension and whose medical condition make them eligible for treatment with Telmisartan/Telmisartan+HCTZ
Key exclusion criteria (9 listed)
- Pre-menopausal women who had had no birth control, who are pregnant or nursing
- Patients with advanced hepatic impairment, advanced renal impairment or both
- Patients with functional class III or IV (NYHA) congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months
- Patients with any valvular disease with hemodynamic repercussion
- Patients receiving chronic administration of oral anticoagulants or digoxin
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 |
|---|---|---|
| telmisartan | Drug | – |
Primary outcome
Change from baseline in mean early morning systolic blood pressure, mean early morning diastolic blood pressure, and degree of control. (6:00 to 11:59), BP < 135/85 mmHg. (HBPM: mean of morning measurements).
Time frame: 217 Weeks
1 secondary outcome
Clinical control (office BP), response rates, reduction in office cuff systolic and diastolic BP. Office BP control criteria: BP < 140/90 mmHg. Pulse rate, pulse pressure, discontinuations and tolerability.
Time frame: 217 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 5 Nov 2019.
- Related InfoLink provided by the sponsor.
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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 chair
Boehringer Ingelheim
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Boehringer Ingelheim at 12 sites in 12 countries.
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 9 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 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium, Canada, Colombia, Czechia, Ecuador and 7 more countries. 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.
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 from baseline in mean early morning systolic blood pressure, mean early morning diastolic blood pressure, and degree of control. (6:00 to 11:59), BP < 135/85 mmHg. (HBPM: mean of morning measurements). (time frame: 217 Weeks). 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 5 Nov 2019.