HypertensionNCT02242357
Study to Evaluate Efficacy and Tolerability of Micardis®/Micardis® Plus in Patients With Hypertension
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
Study to evaluate efficacy and tolerability of Micardis®/Micardis® Plus under usual daily-practice prescribing conditions in hypertensive patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Micardis® and Micardis® Plus
- How many people
- 14,553 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jul 2003
- 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 hypertension
Who may be able to join
- Males and females for whom a medical antihypertensive therapy is indicated
- Age >= 18 years
Who cannot join
- Age < 18 years
About this study
Official title: Post-Marketing Surveillance Study Micardis® Plus
Study to evaluate efficacy and tolerability of Micardis®/Micardis® Plus under usual daily-practice prescribing conditions in hypertensive patients
- Conditions
- Hypertension
- Being tested
- Micardis®, Micardis® Plus
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micardis®Drug
Micardis® PlusDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients with hypertension | Not described Receives: Drug: Micardis®; Drug: Micardis® Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in morning blood pressure (office and self-measured)
Measured: up to 6 weeks
Secondary outcomes (5)
Change in heart rate
Measured: up to 6 weeks
Number of patients with adverse drug reactions
Measured: up to 6 weeks
Assessment of efficacy by investigator on a 5-point scale
Measured: at week 6
Assessment of tolerability by investigator on 5-point scale
Measured: at week 6
Change in rate of morning complaints
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 startJan 2003
- Primary completionJul 2003
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
- 14,553 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
- NCT02242357
- Sponsor's protocol ID
- 502.427
- 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
- Post-Marketing Surveillance Study Micardis® Plus
- ClinicalTrials.gov ID
- NCT02242357
- Acronym / sponsor ID
- 502.427
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,553 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Jul 2003 (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 evaluate efficacy and tolerability of Micardis®/Micardis® Plus under usual daily-practice prescribing conditions in hypertensive patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hypertension | – | Drug: Micardis®, Drug: Micardis® Plus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with hypertension
Key inclusion criteria (2 listed)
- Males and females for whom a medical antihypertensive therapy is indicated
- Age >= 18 years
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 |
|---|---|---|
| Micardis® | Drug | Patients with hypertension |
| Micardis® Plus | Drug | Patients with hypertension |
Primary outcome
Change in morning blood pressure (office and self-measured)
Time frame: up to 6 weeks
5 secondary outcomes
Change in heart rate
Time frame: up to 6 weeks
Number of patients with adverse drug reactions
Time frame: up to 6 weeks
Assessment of efficacy by investigator on a 5-point scale
Time frame: at week 6
Assessment of tolerability by investigator on 5-point scale
Time frame: at week 6
Change in rate of morning complaints
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.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
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)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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 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.
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 morning blood pressure (office and self-measured) (time frame: up to 6 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 17 Sep 2014.