HypertensionNCT02262611
Post Marketing Surveillance Study in Rehabilitation Clinics (Cardio, Nephro, Diabetes, Pulmo)
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
Study to obtain long-term data on effects, safety and tolerability in routine medical practice and to investigate the potential of telmisartan to prevent secondary organ damage 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 MicardisPlus®
- How many people
- 266 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Dec 2005
- 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: Patients with hypertension recruited at hospitals in Germany specialized in cardiology, nephrology, diabetology and pneumology
Who may be able to join
- Adult patients of both gender aged >=18 admitted to a hospital due to insufficiently controlled essential hypertension.
- No additional selection criteria have to be considered. Treatment was at the discretion of the physician following the summary of product information for Micardis® and MicardisPlus®
Who cannot join
- not applicable
About this study
Study to obtain long-term data on effects, safety and tolerability in routine medical practice and to investigate the potential of telmisartan to prevent secondary organ damage
- Conditions
- Hypertension
- Being tested
- Micardis®, MicardisPlus®
- 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
MicardisPlus®Drug
| Study group | Role | What they receive |
|---|---|---|
| Hypertension patients - Pneumology | Not described Receives: Drug: Micardis®; Drug: MicardisPlus® | |
| Hypertension patients - Cardiology | Not described Receives: Drug: Micardis®; Drug: MicardisPlus® | |
| Hypertension patients - Nephrology | Not described Receives: Drug: Micardis®; Drug: MicardisPlus® | |
| Hypertension patients - Diabetology | Not described Receives: Drug: Micardis®; Drug: MicardisPlus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: up to 1 year
Number of patients with abnormal changes in laboratory parameters
Measured: up to 1 year
Number of patients with clinically significant changes in vital signs
Measured: up to 1 year
Change in systolic blood pressure
Measured: up to 1 year
Change in diastolic blood pressure
Measured: up to 1 year
Secondary outcomes (2)
Global assessment of efficacy by investigator on a 4-point scale
Measured: 2 weeks, after 1 year
Global assessment of tolerability by investigator on a 4-point scale
Measured: 2 weeks, after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJan 2003
- Primary completionDec 2005
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
- 266 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
- NCT02262611
- Sponsor's protocol ID
- 502.428
- Other IDs
- 502.429, 502.430, 502.431
- Status last verified
- Oct 2014
- First submitted
- 10 Oct 2014
- Last updated
- 13 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study in Rehabilitation Clinics (Cardio, Nephro, Diabetes, Pulmo)
- ClinicalTrials.gov ID
- NCT02262611
- Acronym / sponsor ID
- 502.428
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Dec 2005 (actual)
- First posted
- 13 Oct 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 obtain long-term data on effects, safety and tolerability in routine medical practice and to investigate the potential of telmisartan to prevent secondary organ damage
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypertension patients - Pneumology | – | Drug: Micardis®, Drug: MicardisPlus® |
| Hypertension patients - Cardiology | – | Drug: Micardis®, Drug: MicardisPlus® |
| Hypertension patients - Nephrology | – | Drug: Micardis®, Drug: MicardisPlus® |
| Hypertension patients - Diabetology | – | Drug: Micardis®, Drug: MicardisPlus® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hypertension recruited at hospitals in Germany specialized in cardiology, nephrology, diabetology and pneumology
Key inclusion criteria (2 listed)
- Adult patients of both gender aged >=18 admitted to a hospital due to insufficiently controlled essential hypertension.
- No additional selection criteria have to be considered. Treatment was at the discretion of the physician following the summary of product information for Micardis® and MicardisPlus®
Key exclusion criteria (1 listed)
- not applicable
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 | Hypertension patients - Cardiology, Hypertension patients - Diabetology, Hypertension patients - Nephrology, Hypertension patients - Pneumology |
| MicardisPlus® | Drug | Hypertension patients - Cardiology, Hypertension patients - Diabetology, Hypertension patients - Nephrology, Hypertension patients - Pneumology |
Primary outcome
Number of patients with adverse events
Time frame: up to 1 year
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 1 year
Number of patients with clinically significant changes in vital signs
Time frame: up to 1 year
Change in systolic blood pressure
Time frame: up to 1 year
Change in diastolic blood pressure
Time frame: up to 1 year
2 secondary outcomes
Global assessment of efficacy by investigator on a 4-point scale
Time frame: 2 weeks, after 1 year
Global assessment of tolerability by investigator on a 4-point scale
Time frame: 2 weeks, after 1 year
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 13 Oct 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 13 Oct 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?
Number of patients with adverse events (time frame: up to 1 year). The study lists 5 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 13 Oct 2014.