HypertensionPhase 4NCT02260089
Telmisartan in Mild to Moderate Hypertensive Patients
A Phase 4 study testing Low dose of telmisartan and High dose of telmisartan in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Low dose of telmisartan and High dose of telmisartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Mar 2000to Jul 2002
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with blood pressure levels of 140/90 mm Hg or higher (confirmed on 2 consecutive visits), who were 18 years old and older, regardless of sex
Who cannot join
- Suspected or known diagnosis of arterial hypertension with a secondary cause
- Women who were not using an effective method of contraception, or who were pregnant, or breast-feeding
- Systolic blood pressure > 200 mm Hg or diastolic blood pressure > 115 mm Hg
- Laboratory test values two fold above the upper normal limit
- Previous intolerance to angiotensin conversion enzyme inhibitors or angiotensin II blocker (AIIAR)
- New York Heart Association class III or IV heart failure
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- History of stroke in the 6 months prior to entry into the study
- Uncontrolled type 2 diabetes mellitus, defined as fasting glucose levels > 140 mg/dL on 3 consecutive assessments
- Patients who were included in another investigational drug study in the past 30 days
About this study
Official title: A Multicenter Open-label Study of the Efficacy and Safety of Telmisartan in Mild to Moderate Hypertensive Patients
To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM
- Conditions
- Hypertension
- Being tested
- Low dose of telmisartan, High dose of telmisartan, Placebo
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Low dose of telmisartan | Experimental | 4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan Receives: Drug: Low dose of telmisartan; Drug: Placebo |
| High dose of telmisartan | Experimental | After 6 weeks of treatment with low dose of telmisartan, titration to high dose of telmisartan if blood pressure level is higher than 140/90 mm Hg Receives: Drug: High dose of telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Blood pressure values were obtained 24 hours after the last dose (through values) at the office
Measured: Baseline, up to 12 weeks after start of treatment
Secondary outcomes (5)
Assessment of treatment response for SBP/DBP (in %)
Response categories:
- SBP < 140 mm Hg or
- DBP < 90 mm Hg or
- BP reduction ≥ 10 mm Hg
Measured: Baseline, up to 12 weeks after start of treatment
Changes from baseline in blood pressure values
Analysis performed for the ambulatory blood pressure monitoring (ABPM) - subgroup
Measured: Baseline, up to 12 weeks after start of treatment
Number of patients with adverse events
Measured: Up to 16 weeks
Number of patients with clinically significant changes in laboratory values
Measured: Up to 16 weeks
Number of patients with clinically significant changes in ECG
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startMar 2000
- Primary completionJul 2002
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
- 134 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
- NCT02260089
- Sponsor's protocol ID
- 502.363
- Status last verified
- Oct 2014
- First submitted
- 8 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-label Study of the Efficacy and Safety of Telmisartan in Mild to Moderate Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02260089
- Acronym / sponsor ID
- 502.363
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2000
- Primary completion
- Jul 2002 (actual)
- First posted
- 9 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.
To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose of telmisartan | Experimental | Drug: Low dose of telmisartan, Drug: Placebo4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan |
| High dose of telmisartan | Experimental | Drug: High dose of telmisartanAfter 6 weeks of treatment with low dose of telmisartan, titration to high dose of telmisartan if blood pressure level is higher than 140/90 mm Hg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with blood pressure levels of 140/90 mm Hg or higher (confirmed on 2 consecutive visits), who were 18 years old and older, regardless of sex
Key exclusion criteria (9 listed)
- Suspected or known diagnosis of arterial hypertension with a secondary cause
- Women who were not using an effective method of contraception, or who were pregnant, or breast-feeding
- Systolic blood pressure > 200 mm Hg or diastolic blood pressure > 115 mm Hg
- Laboratory test values two fold above the upper normal limit
- Previous intolerance to angiotensin conversion enzyme inhibitors or angiotensin II blocker (AIIAR)
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 | Low dose of telmisartan |
| High dose of telmisartan | Drug | High dose of telmisartan |
| Placebo | Drug | Low dose of telmisartan |
Primary outcome
Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Time frame: Baseline, up to 12 weeks after start of treatment
Blood pressure values were obtained 24 hours after the last dose (through values) at the office
5 secondary outcomes
Assessment of treatment response for SBP/DBP (in %)
Time frame: Baseline, up to 12 weeks after start of treatment
Changes from baseline in blood pressure values
Time frame: Baseline, up to 12 weeks after start of treatment
Number of patients with adverse events
Time frame: Up to 16 weeks
Number of patients with clinically significant changes in laboratory values
Time frame: Up to 16 weeks
Number of patients with clinically significant changes in ECG
Time frame: Up to 16 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 9 Oct 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 1 inclusion and 9 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 9 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.
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?
Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) (time frame: Baseline, up to 12 weeks after start of treatment). 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 9 Oct 2014.