HypertensionNCT02200575
Pharmacovigilance and Patient Compliance in Hypertensive Patients
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan
- How many people
- 10,333 participants
- Where
- No sites listed yet
- Study dates
- May 1999to Dec 2000
- 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 over 18 years of age suffering non-secondary, essential hypertension, treated by general practitioners and/or specialists
Who may be able to join
- Patients of either sex over the age of 18 years suffering from non-secondary essential hypertension with values of at least 90 mmHg (diastolic) and 140 mmHg (systolic)
Who cannot join
- corresponding to the contraindications listed in the summary of product characteristics of the drug
About this study
Official title: Pharmacovigilance and Patient Compliance in Hypertensive Patients. Observational Study
Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to control blood pressure for 24 hours, especially during the last few hours of the dosage interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and to confirm the efficacy and possible risks associated with treatment.
- 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
Also called Micardis®
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-secondary, essential hypertension | Not described Receives: Drug: Telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in heart rate
Measured: Baseline, up to 8 weeks after start of treatment
Assessment for patients with changes in laboratory values
Measured: Baseline, up to 8 weeks after start of treatment
Number of patients with adverse events
Measured: Up to 8 weeks after start of treatment
Secondary outcomes (3)
Changes in mean systolic and diastolic blood pressure values
Measured by means of ambulatory blood pressure monitoring (ABPM) over 24 hours
Measured: Baseline, up to 8 weeks after start of treatment
Changes in mean systolic and diastolic blood pressure values
Measured three times at intervals of two minutes with the patient seated and lying down for 5 minutes, using a sphygmomanometer
Measured: Baseline, up to 8 weeks after start of treatment
Evaluation of treatment compliance as percentage of tablets planned
(number of tablets taken / total number of days) x 100
Measured: Up to 8 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startMay 1999
- Primary completionDec 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,333 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
- NCT02200575
- Sponsor's protocol ID
- 502.359
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacovigilance and Patient Compliance in Hypertensive Patients. Observational Study
- ClinicalTrials.gov ID
- NCT02200575
- Acronym / sponsor ID
- 502.359
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,333 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 1999
- Primary completion
- Dec 2000 (actual)
- First posted
- 25 Jul 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 confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to control blood pressure for 24 hours, especially during the last few hours of the dosage interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and to confirm the efficacy and possible risks associated with treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with non-secondary, essential hypertension | – | Drug: Telmisartan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients over 18 years of age suffering non-secondary, essential hypertension, treated by general practitioners and/or specialists
Key inclusion criteria (1 listed)
- Patients of either sex over the age of 18 years suffering from non-secondary essential hypertension with values of at least 90 mmHg (diastolic) and 140 mmHg (systolic)
Key exclusion criteria (1 listed)
- corresponding to the contraindications listed in the summary of product characteristics of the drug
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 |
|---|---|---|
| TelmisartanAlso: Micardis® | Drug | Patients with non-secondary, essential hypertension |
Primary outcome
Assessment of changes in heart rate
Time frame: Baseline, up to 8 weeks after start of treatment
Assessment for patients with changes in laboratory values
Time frame: Baseline, up to 8 weeks after start of treatment
Number of patients with adverse events
Time frame: Up to 8 weeks after start of treatment
3 secondary outcomes
Changes in mean systolic and diastolic blood pressure values
Time frame: Baseline, up to 8 weeks after start of treatment
Changes in mean systolic and diastolic blood pressure values
Time frame: Baseline, up to 8 weeks after start of treatment
Evaluation of treatment compliance as percentage of tablets planned
Time frame: Up to 8 weeks after start of treatment
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 25 Jul 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 1 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 25 Jul 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?
Assessment of changes in heart rate (time frame: Baseline, up to 8 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 25 Jul 2014.