Investigating the Effect of Telmisartan (Micardis®) on the Average 24h Blood Pressure of Therapy-naive and Therapy-experienced Patients

An observational study of Hypertension, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients Read more about this study

Who is it for?: Ages 18 to 95 years
Conditions the study is for: Hypertension
What is being tested?: Micardis
How many people: 670 participants
Where: No sites listed yet
Study dates: Apr 2009to Jan 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 95 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: hypertensive patients

Who may be able to join

Patients who have recently been diagnosed with hypertension
Patients whose current blood pressure treatment are inadequate and needs to be revised are suitable for inclusion.

Who cannot join

None (according to investigator)

About this study

Official title: 24h BP Under Micardis in Daily Practice

Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients

Conditions: Hypertension
Being tested: Micardis
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MicardisDrug

Study groups in NCT00879411
Study group	Role	What they receive
arterial hypertension		Not described Receives: Drug: Micardis

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy (Change of Systolic Blood Pressure)
Change from baseline in 24h systolic blood pressure (BP) at week 8
Measured: baseline to 8 weeks
Efficacy (Change of Diastolic Blood Pressure)
Change from baseline in 24h diastolic blood pressure (BP) at week 8
Measured: baseline to 8 weeks

Secondary outcomes (1)

Overall Tolerability Scale
Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jan 2010

First posted10 Apr 2009 (estimated)
Study startApr 2009
Primary completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Case only
Time perspective: Prospective
Enrolment: 670 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00879411
Sponsor's protocol ID: 502.582
Status last verified: Feb 2014
First submitted: 9 Apr 2009
Last updated: 28 Mar 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 24h BP Under Micardis in Daily Practice
ClinicalTrials.gov ID: NCT00879411
Acronym / sponsor ID: 502.582
Conditions: Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 670 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Jan 2010 (actual)
First posted: 10 Apr 2009 (estimated)
Results: Posted 15 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
arterial hypertension	–	Drug: Micardis

Who may qualify

Ages: 18 to 95 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: hypertensive patients

Key inclusion criteria (2 listed)

Patients who have recently been diagnosed with hypertension
Patients whose current blood pressure treatment are inadequate and needs to be revised are suitable for inclusion.

Key exclusion criteria (1 listed)

None (according to investigator)

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
Micardis	Drug	arterial hypertension

Primary outcome

Efficacy (Change of Systolic Blood Pressure)
Time frame: baseline to 8 weeks
Change from baseline in 24h systolic blood pressure (BP) at week 8
Efficacy (Change of Diastolic Blood Pressure)
Time frame: baseline to 8 weeks
Change from baseline in 24h diastolic blood pressure (BP) at week 8

1 secondary outcome

Overall Tolerability Scale
Time frame: 8 weeks

Results and safety

Results posted to the registry on 15 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telmisartan, Hydrochlorothiazide	701	539

Primary outcome: Efficacy (Change of Systolic Blood Pressure)

Time frame: baseline to 8 weeks. Mean (Standard Deviation). Unit: mm Hg

Measure	Telmisartan, Hydrochlorothiazide n = 537
Value	8.6 (17.8)

Population analysed: Intention to Treat (ITT)

Primary outcome: Efficacy (Change of Diastolic Blood Pressure)

Time frame: baseline to 8 weeks. Mean (Standard Deviation). Unit: mm Hg

Measure	Telmisartan, Hydrochlorothiazide n = 537
Value	4.7 (12.7)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 56 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telmisartan, Hydrochlorothiazide	0 of 701 (0%)	0 of 701 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

Active, not recruiting
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Chronic Kidney Disease, Hypertension (HTN)
Recruiting
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Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
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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

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 28 Mar 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?

Yes. Results are posted in the registry (first posted 15 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Efficacy (Change of Systolic Blood Pressure) (time frame: baseline to 8 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 NCT00879411.

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 28 Mar 2014.