HypertensionPhase 4MicCATNCT02242370
Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Live in Patients With Essential Hypertension
A Phase 4 study testing Low dose of telmisartan and High dose of telmisartan in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to establish the effect on patient's quality of life scores. Read more about this study
- Who is it for?
- Ages 20 to 93 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Low dose of telmisartan and High dose of telmisartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,045 participants
- Where
- No sites listed yet
- Study dates
- Sep 1999to Nov 2000
- 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 20 to 93 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Stage I essential Hypertension (diastolic blood pressure 90-99 mmHg, and/or systolic blood pressure 140-159 mmHg)
- Signed informed consent form
Who cannot join
- Females of childbearing potential
About this study
Official title: An Open-label Evaluation of the Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Life in Patients With Essential Hypertension The MICARDIS COMMUNITY ACCESS TRIAL (MicCAT)
Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to establish the effect on patient's quality of life scores.
- Conditions
- Hypertension
- Being tested
- Low dose of telmisartan, High dose of telmisartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of telmisartanDrug
High dose of telmisartanDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan low dose | Experimental | Not described Receives: Drug: Low dose of telmisartan |
| Telmisartan high dose | Experimental | Not described Receives: Drug: High dose of telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diastolic blood pressure
Measured: Pre-dose, up to 6 weeks after start of treatment
Change in systolic blood pressure
Measured: Pre-dose, up to 6 weeks after start of treatment
Changes from baseline in the quality of life (QOL) scores by patient self-assessment
Measured: Pre-dose, 6 weeks after start of treatment
Secondary outcomes (5)
Assessment of blood pressure control rate
Measured: Up to 6 weeks after start of treatment
Assessment of systolic blood pressure response rate
Measured: Up to 6 weeks after start of treatment
Assessment of diastolic blood pressure response rate
Measured: Up to 6 weeks after start of treatment
Change from baseline in pulse pressure
Measured: Pre-dose, up to 6 weeks after start of treatment
Number of patients with adverse events
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 1999
- Primary completionNov 2000
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,045 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
- NCT02242370
- Sponsor's protocol ID
- 502.461
- Acronym
- MicCAT
- Status last verified
- Sep 2014
- First submitted
- 16 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Evaluation of the Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Life in Patients With Essential Hypertension The MICARDIS COMMUNITY ACCESS TRIAL (MicCAT)
- ClinicalTrials.gov ID
- NCT02242370
- Acronym / sponsor ID
- MicCAT / 502.461
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,045 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 1999
- Primary completion
- Nov 2000 (actual)
- First posted
- 17 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.
Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to establish the effect on patient's quality of life scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan low dose | Experimental | Drug: Low dose of telmisartan |
| Telmisartan high dose | Experimental | Drug: High dose of telmisartan |
Who may qualify
- Ages
- 20 to 93 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Stage I essential Hypertension (diastolic blood pressure 90-99 mmHg, and/or systolic blood pressure 140-159 mmHg)
- Signed informed consent form
Key exclusion criteria (1 listed)
- Females of childbearing potential
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 |
|---|---|---|
| Low dose of telmisartan | Drug | Telmisartan low dose |
| High dose of telmisartan | Drug | Telmisartan high dose |
Primary outcome
Change in diastolic blood pressure
Time frame: Pre-dose, up to 6 weeks after start of treatment
Change in systolic blood pressure
Time frame: Pre-dose, up to 6 weeks after start of treatment
Changes from baseline in the quality of life (QOL) scores by patient self-assessment
Time frame: Pre-dose, 6 weeks after start of treatment
5 secondary outcomes
Assessment of blood pressure control rate
Time frame: Up to 6 weeks after start of treatment
Assessment of systolic blood pressure response rate
Time frame: Up to 6 weeks after start of treatment
Assessment of diastolic blood pressure response rate
Time frame: Up to 6 weeks after start of treatment
Change from baseline in pulse pressure
Time frame: Pre-dose, up to 6 weeks after start of treatment
Number of patients with adverse events
Time frame: Up to 6 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 17 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?
A Phase 4 study testing Low dose of telmisartan and High dose of telmisartan in people with 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 17 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.
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 diastolic blood pressure (time frame: Pre-dose, up to 6 weeks after start of treatment). 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?
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 17 Sep 2014.